System and method for safety syringe

ABSTRACT

One embodiment is directed to a system for injecting, comprising a syringe body defining an interior medicine chamber; a stopper member configured to be inserted into the interior medicine chamber to contain medicine within the medicine chamber; a plunger member configured to be manually manipulated to insert the stopper member relative to the syringe body; and a needle having proximal and distal ends, the proximal end comprising an anchoring geometry configured to be at least partially inserted into the stopper member such that upon retraction of the stopper member, the needle is pulled proximally along with the stopper to be at least partially contained within the interior medicine chamber.

RELATED APPLICATION DATA

The present application is a continuation of U.S. patent applicationSer. No. 14/696,342 filed on Apr. 24, 2015, which claims the benefitunder 35 U.S.C. §119 to U.S. provisional patent application Ser. No.61/984,033 filed Apr. 24, 2014, U.S. provisional patent application Ser.No. 62/014,035, filed Jun. 18, 2014. U.S. provisional patent applicationSer. No. 62/059,110, filed Oct. 2, 2014, U.S. provisional patentapplication Ser. No. 62/105,717, filed Jan. 20, 2015, U.S. provisionalpatent application Ser. No. 62/117,672, filed Feb. 18, 2015 and U.S.provisional patent application Ser. No. 62/150,761, filed Apr. 21, 2015.The foregoing applications are hereby incorporated by reference into thepresent application in in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to injection systems, devices,and processes for facilitating various levels of control over fluidinfusion, and more particularly to systems and methods related to safetysyringes in healthcare environments.

BACKGROUND

Millions of syringes, such as that depicted in FIG. 1A (2), are consumedin healthcare environments every day. A typical syringe (2) comprises atubular body (4), a plunger (6), and an injection needle (8). As shownin FIG. 1B, such a syringe (2) may be utilized not only to inject fluidinto a patient, but also to withdraw or expel fluid out of or into acontainer such as a medicine bottle, vial, bag, or other drugcontainment system (10). Indeed, due to regulatory constraints in somecountries such as the United States as well as sterility maintenanceconcerns, upon use of a medicine bottle (10) with a syringe (2) as shownin a particular patient's environment, such medicine bottle may only beutilized with a single patient and then must be disposed of—causingsignificant medical waste from bottle and remaining medicine disposal,and even contributing to periodic shortages of certain critical drugs.Referring to FIG. 2A, three Luer-type syringes (12) are depicted, eachhaving a Luer fitting geometry (14) disposed distally, so that they maybe coupled with other devices having similar mating geometry, such asthe Luer manifold assembly (16) depicted in FIG. 2B. The Luer fittings(14) of the syringes of FIG. 2A may be termed the “male” Luer fittings,while those of FIG. 2B (18) may be termed the “female” Luer fittings;one of the Luer interfaces may be threaded (in which case theconfiguration may be referred to as a “Luer lock” configuration) so thatthe two sides may be coupled by relative rotation, which may be combinedwith compressive loading. In other words, in one Luer lock embodiment,rotation, possibly along with compression, may be utilized to engagethreads within the male fitting which are configured to engage a flangeon the female fitting and bring the devices together into a fluid-sealedcoupling. In another embodiment, tapered interfacing geometries may beutilized to provide for a Luer engagement using compression withoutthreads or rotation (such a configuration may be referred to as a“slip-on” or “conical” Luer configuration). While such Luer couplingsare perceived to be relatively safe for operators, there is risk ofmedicine spilling/leaking and parts breakage during the loading toprovide a Luer coupling. The use of needle injection configurations, onthe other hand, carries with it the risk of a sharp needle contacting orpoking a person or structure that is not desired. For this reason, socalled “safety syringes” have been developed.

One embodiment of a safety syringe (20) is shown in FIG. 3, wherein atubular shield member (22) is spring biased to cover the needle (8) whenreleased from a locked position relative to the syringe body (4).Another embodiment of a safety syringe (24) is shown in FIGS. 4A-4B.With such a configuration, after full insertion of the plunger (6)relative to the syringe body (4), the retractable needle (26) isconfigured to retract (28, 26) back to a safe position within thetubular body (4), as shown in FIG. 4B. Such a configuration which isconfigured to collapse upon itself may be associated with bloodspatter/aerosolization problems, the safe storage of pre-loaded energywhich may possible malfunction and activate before desirable, loss ofaccuracy in giving full-dose injections due to residual dead spacewithin the spring compression volume, and/or loss of retraction velocitycontrol which may be associated with pain and patient anxiety.

Further complicating the syringe marketplace is an increasing demand forpre-filled syringe assemblies such as those depicted in FIGS. 5A and 5B,which generally comprise a syringe body, or “drug enclosure containmentdelivery system”, (34), a plunger tip, plug, or stopper (36), and adistal seal or cap (35) which may be fitted over a Luer type interface(FIG. 5A shows the cap 35 in place; FIG. 5B has the cap removed toillustrate the Luer interface 14). Liquid medicine may reside in thevolume, or medicine reservoir, (40) between the distal seal and thedistal end (37) of the plunger tip (36). The plunger tip (36) maycomprise a standard butyl rubber material and may be coated, such aswith a biocompatible lubricious coating, to facilitate preferred sealingand relative motion characteristics against the associated syringe bodystructure and material. The proximal end of the syringe body (34) inFIG. 5B comprises a conventional syringe flange (38), such as that knownas a “Gerresheimer” flange configuration. The syringe body (34)preferably comprises a translucent material such as a glass or polymer.To form a contained volume within the medicine chamber or reservoir(40), and to assist with expulsion of the associated fluid through theneedle, a plunger tip (36) may be positioned within the syringe body(34). The syringe body may define a substantially cylindrical shape(i.e., so that a plunger tip 36 having a circular cross sectional shapemay establish a seal against the syringe body), or be configured to haveother cross sectional shapes, such as an ellipse.

Such assemblies are desirable because they may be standardized andproduced with precision in volume by the few manufacturers in the worldwho can afford to meet all of the continually changing regulations ofthe world for filling, packaging, and medicine/drug interfacingmaterials selection and component use. Such simple configurations,however, generally will not meet the new world standards for single-use,safety, auto-disabling, and anti-needle-stick. Thus certain suppliershave moved to more “vertical” solutions, such as that (41) featured inFIG. 5C, which attempts to meet all of the standards, or at least aportion thereof, with one solution; as a result of trying to meet thesestandards for many different scenarios, such products may havesignificant limitations (including some of those described above inreference to FIGS. 3-4B) and relatively high inventory and utilizationexpenses.

There is a need for improved injection systems which address theshortcomings of currently-available configurations. In particular, thereis a need for safety injection solutions which may utilize the existingand relatively well-controlled supply chain of conventionally deliveredpre-filled syringe assemblies such as those described in reference toFIGS. 5A and 5B.

SUMMARY

One embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having proximal and distal ends, the proximalend comprising an anchoring geometry configured to be at least partiallyinserted into the stopper member such that upon retraction of thestopper member, the needle is pulled proximally along with the stopperto be at least partially contained within the interior medicine chamber.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; a needle having proximal and distal ends; and a couplingmember operatively coupled to the syringe body and needle, the couplingmember having a first state wherein the needle is removably coupled tothe syringe body, and a second state wherein the needle is free toretract relative to the syringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and a distal needleinterface; a stopper member configured to be inserted into the interiormedicine chamber to contain medicine within the medicine chamber, thestopper member having proximal and distal ends; a plunger memberconfigured to be manually manipulated to insert the stopper memberrelative to the syringe body; a needle having proximal and distal ends,the proximal end coupled to the distal needle interface of the syringebody; wherein the distal end of the stopper member is configured to haveno pre-formed needle coupling features.

Another embodiment is directed to a system for injecting, comprising: asyringe body defining an interior medicine chamber and a distal needleinterface defining a Luer taper; a stopper member configured to beinserted into the interior medicine chamber to contain medicine withinthe medicine chamber, the stopper member having proximal and distalends; a plunger member configured to be manually manipulated to insertthe stopper member relative to the syringe body; a needle havingproximal and distal ends, the proximal end coupled to the distal needleinterface of the syringe body; wherein the needle proximal end isconfigured to be removably coupled to an external surface of the Luertaper.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and a distal needleinterface; a stopper member configured to be inserted into the interiormedicine chamber to contain medicine within the medicine chamber; aplunger member configured to be manually manipulated to insert thestopper member relative to the syringe body; and a needle havingproximal and distal ends, the proximal end configured to be coupled tothe stopper member upon insertion of the stopper member to afully-inserted position, such that upon retraction of the stoppermember, the needle is pulled proximally along with the stopper to becontained within the interior medicine chamber; wherein upon retractionof the needle into the interior medicine chamber to a position whereinthe distal end of the needle is contained within the interior medicinechamber, the needle becomes misaligned with a longitudinal axis of thesyringe body such that it is prevented from being reinserted out of theinterior medicine chamber.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; a needle having a sharpened distal end; and a needle doormember movably coupled the syringe body and configured to have a firststate wherein the needle door member facilitates insertion of the needlerelative to the syringe body, and a second state wherein the needle doormember prevents insertion of the needle relative to the syringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and a distal needleinterface defining a Luer taper; a stopper member configured to beinserted into the interior medicine chamber to contain medicine withinthe medicine chamber, the stopper member having proximal and distalends; a plunger member configured to be manually manipulated to insertthe stopper member relative to the syringe body; a medicine capremovably coupled to the distal needle interface and configured to sealthe interior medicine chamber; a needle having proximal and distal ends,the proximal end comprising a coupling portion configured to beremovably coupled to an external surface of the Luer taper after themedicine cap has been removed, and a retraction portion configured tobecome coupled to the stopper member such that upon withdrawal of thestopper member relative to the syringe body, the needle may be withdrawnrelative to the syringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; a needle having sharpened proximal and distal ends; and aneedle cover member defining an inner volume configured to temporarilyhouse and protect at least a sharpened distal end of the needle, whilealso aligning a sharpened proximal end of the needle for interfacingwith the syringe body when installed by a user.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; a needle having sharpened proximal and distal ends; and aneedle cover member defining an inner volume configured to temporarilyhouse and protect at least a sharpened distal end of the needle, theneedle cover member removably couplable to the needle with at least onesnap-over detent interface.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having proximal and distal ends and an airbubble exit lumen defined therebetween, the air bubble exit lumencomprising an entry port defined into the needle and positionedimmediately adjacent a distal end of the medicine chamber such that airbubbles within the medicine chamber may be expelled with insertion ofthe stopper member regardless of the level of protrusion of the proximalend of the needle into the medicine chamber.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having sharpened proximal and distal ends; adistal seal element having proximal and distal ends and being sealablydisposed within the medicine chamber, the distal seal element beingreleasably couplable to the needle proximal end such that a sealedinterface may be provided therebetween; wherein in a first coupled mode,the sharpened proximal end of the needle is positioned at leastpartially through the distal seal element such that the distal sealelement grips onto the needle proximal end; and wherein in a secondrelease mode, a dilating element dilates the interface between thedistal seal element and the sharpened proximal end of the needle suchthat the needle becomes releasable from the distal seal element.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; a needle having sharpened proximal and distal ends; adistal seal element removably coupled around at least a portion of theproximal end of the needle and configured to grip onto the proximal endof the needle until dilated away therefrom; and a dilating elementcoupled to the needle proximal end and configured to dilate the distalseal element away from the proximal end of the needle to release theneedle from the distal seal element by advancement of the distal sealelement toward the dilating element while the dilating element andintercoupled needle remain substantially stationary relative to thesyringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; a needle having proximal and distal ends, the proximal endcoupled to a distal end of the syringe body; and a needle sheathoperatively coupled to the syringe body and defining a lumen throughwhich at least the distal end of the needle may be passed, the needlesheath configured to have a first state, wherein the needle sheath iscompressed toward the proximal end of the needle to expose the distalend of the needle for injecting, and a second state, wherein the needlesheath is advanced forward over the needle distal end to substantiallycover the needle and prevent contact with the distal end of the needle;wherein in the first state, an energy storage member is compressed tobias the needle sheath to spring forward into the second state but for asheath retention element which retains the needle sheath in the firstposition until the stopper member has been advanced to a predeterminedposition relative to the syringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; a needle having proximal and distal ends, the proximal endcoupled to a distal end of the syringe body; and a telescoping needlesheath operatively coupled to the syringe body and defining a lumenthrough which at least the distal end of the needle may be passed, theneedle sheath configured to have a first state, wherein the telescopingneedle sheath is telescopically compressed toward the proximal end ofthe needle to expose the distal end of the needle for injecting, and asecond state, wherein the needle sheath is telescopically advancedforward over the needle distal end to substantially cover the needle andprevent contact with the distal end of the needle; wherein in the firststate, an energy storage member is compressed to bias the needle sheathto spring forward into the second state but for a sheath retentionelement which retains the needle sheath in the first position until thestopper member has been advanced to a predetermined position relative tothe syringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and a distal needleinterface comprising a Luer taper defining an inner surface that isfluidly coupled to the interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having proximal and distal ends, the proximalend removably attached to the inner surface of the Luer taper.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and a distal needleinterface; a stopper member configured to be inserted into the interiormedicine chamber to contain medicine within the medicine chamber; aplunger member configured to be manually manipulated to insert thestopper member relative to the syringe body; a needle having proximaland distal ends, the proximal end removably attached to the syringe bodydistal needle interface; and a needle seal operatively coupled betweenthe needle and distal needle interface, the needle seal configured toprevent fluid flow between an outer surface of the needle and the distalneedle interface; wherein the needle is coupled to at least oneradially-projecting latching feature, the latching feature configured tointerface with a mechanical latch to prevent axial movement of theneedle relative to the syringe in a latched configuration, and tofacilitate movement of the needle of the needle relative to the syringebody in an unlatched configuration.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and a distal needleinterface; a stopper member configured to be inserted into the interiormedicine chamber to contain medicine within the medicine chamber; aplunger member configured to be manually manipulated to insert thestopper member relative to the syringe body; a needle having proximaland distal ends, the proximal end removably attached to the syringe bodydistal needle interface; a needle seal operatively coupled between theneedle and distal needle interface, the needle seal configured toprevent fluid flow between an outer surface of the needle and the distalneedle interface; and a latching collar coupled to a distal end of thesyringe body, the latching collar configured to have a latching recessand a retraction aperture; wherein the needle is coupled to at least oneleaf spring latching feature, the latching feature having proximal anddistal ends, wherein the distal end is fixedly coupled to the needle,and wherein when unconstrained, the proximal end is free to move incantilevered bending relative to the distal end but is biased to returnto a position substantially flush against the needle; and wherein in alatched configuration, the leaf spring latching feature proximal end iscantilevered into the latching recess to prevent axial retraction of theneedle relative to the syringe body; and wherein upon slight insertionof the needle relative to the syringe body, the leaf spring latchingfeature proximal end is removed from the latching recess and bends backto a position substantially flush against the needle such that theneedle and leaf spring latching feature assume an unlatchedconfiguration and are free to be retracted through the retractionaperture relative to the syringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having proximal and distal ends, the proximalend comprising an anchoring geometry configured to be at least partiallyinserted into the plunger member such that upon retraction of theplunger member, the needle is pulled proximally to be at least partiallycontained within the interior medicine chamber.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having proximal and distal ends, the proximalend comprising an anchoring geometry configured to stab across at leasta portion of the stopper member to form a fluidly sealed couplingbetween the needle proximal end and the stopper member, the fluidlysealed coupling substantially preventing the passage of fluid out acrossthe stopper member at the interface between the needle proximal end andthe stopper member.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and a distal needleinterface; a stopper member configured to be inserted into the interiormedicine chamber to contain medicine within the medicine chamber; aplunger member configured to be manually manipulated to insert thestopper member relative to the syringe body; and a needle havingproximal and distal ends, the proximal end being removably coupled tothe distal needle interface of the syringe body and at least partiallyretractable into the interior medicine chamber upon manipulation of theplunger member relative to the syringe body to transform a plungerlatching member from a latched state to an unlatched state, the plungerlatching member intercoupled between the syringe body and the plungermember; wherein the plunger latching member is substantially disposedwithin a lumen defined by the plunger member. The syringe body maycomprise an off-the-shelf syringe body. The syringe body may comprise agenerally cylindrical geometry. The medicine chamber may be configuredto contain between about 0.5 cc and about 5 cc of medicine. The medicinechamber may be configured to contain a volume of medicine selected fromthe group consisting of: 0.5 cc, 1 cc, 2.25 cc, 3 cc, and 5 cc. Thesyringe body may comprise a glass material. The syringe body maycomprise a polymeric material. The polymeric material may be selectedfrom the group consisting of: COP, COC, polyester, and polypropylene.The syringe body may comprise a metal. The syringe body may comprise adistal outer geometry configured to be mechanically coupled to one ormore other device elements. The syringe body distal outer geometry maycomprise a luer lock interface. The syringe body distal outer geometrymay comprise a luer taper interface. The syringe body may define adistal medicine port. The needle may have a maximum outside diameterselected to be insertable through the distal medicine port of thesyringe body. The distal medicine port may comprise an inner diameter ofabout 1 mm. The needle may have a size between about 34 gauge and about20 gauge. The stopper member may be configured to be at least partiallypierced by a sharpened proximal end of the needle. The needle may haveat least one anchoring element configured to resist pullout subsequentto being at least partially pierced into the stopper member. The atleast one anchoring element may be selected from the group consistingof: a barb, a skive cut, hook geometry, an arrowhead geometry, anundulating radius geometry, an expandable faceted barb configuration,and a deformable member configured to be insertable in a relativelysmall cross-sectional state and to be deformed to a largercross-sectional state. The stopper may have an outer geometry selectedto substantially match an inner geometry of the syringe body tosubstantially seal with the syringe body. The stopper may comprise anelastomeric material selected from the group consisting of: chlorobutylrubber, bromobutyl rubber, and silicon rubber. The system further maycomprise a sealant coating applied to at least a portion of the stopperto isolate medicine materials from the stopper. The sealant coating maycomprise a PTFE film. The system further may comprise a lubricant layerintroduced between the stopper and the syringe body. The lubricant layermay comprise silicon oil. A distal portion of the stopper member maycomprise a conventional off-the-shelf compliant stopper. The stoppermember may comprise an unmodified solid compliant member with norecesses or projections for coupling to a needle. The needle maycomprise at least one radially-projecting latching surface feature. Theproximal end of the needle may comprise at least one piercing elementlocated proximally relative to at least one anchoring element. Thepiercing element may comprise a sharpened tip. The piercing element maycomprise a solid construction without a lumen or aperture definedtherethrough. The needle may define an injection passage therethrough,the injection passage selected to lead from the distal tip of the needleto a location proximal to that of the anchoring element. The needle maycomprise a cannula member, a hub member, and a proximal member. Thecannula member and hub member may be formed from the same piece ofmaterial. The cannula member and hub member may comprise separatelyformed elements that are fixedly coupled together to form portions ofthe needle. The proximal member also may comprise a separately formedelement that is fixedly coupled to the cannula member and hub member toform a portion of the needle. The hub member may be formed from a pieceof tubing. The proximal member may comprise a piece of flat sheet metalhaving a proximal coupling interface. The cannula member may comprise ametal. The hub may comprise a metal or plastic material. The proximalmember may comprise a metal or plastic material. The system further maycomprise an energy-storing member operatively coupled between thestopper member and the syringe body, the energy-storing memberconfigured to facilitate retraction of the stopper member relative tothe syringe body. The plunger member may comprise a plunger member bodythat defines an interior volume, and wherein the energy-storing memberis housed substantially inside of the plunger member body interiorvolume. The system further may comprise a latch member operativelycoupled to the plunger member and housed substantially within theplunger member body interior volume, the latch member being configuredto have a first mechanical state wherein the latch member maintains theenergy storing member in an energy-storing state, and a secondmechanical state wherein the latch member allows the energy-storingmember to release energy stored by the energy-storing member to assistin retraction of the stopper member relative to the syringe body. Thelatch member may comprise a triggering portion configured to extendoutside of the plunger member body interior volume and operativelycouple to the syringe body such that the energy-storing member may beautomatically released when the plunger member and intercoupled stoppermember reach a predetermined insertional position relative to thesyringe body. The predetermined insertional position may be one whereinthe stopper is positioned in a full insertion state relative to thesyringe body. The energy-storing member may be a spring. The spring maycomprise a material selected from the group consisting of: stainlesssteel, carbon steel, beryllium copper alloy, nickel-titanium alloy,chrome-silicon alloy, and cobalt-nickel alloy. The spring may comprisean elastomeric polymer. The elastomeric polymer may be selected from thegroup consisting of: a styrenic polymer, a co-polyester polymer,polyurethane, polyamide, a polyolefin blend, a polyolefin alloy, apolyolefin plastomer, a polyolefin plastomer, and rubber. Theenergy-storing member may comprise a solid pellet member. The solidpellet member may be an elastomeric polymer selected from the groupconsisting of: a styrenic polymer, a co-polyester polymer, polyurethane,polyamide, a polyolefin blend, a polyolefin alloy, a polyolefinplastomer, a polyolefin plastomer, and rubber. The spring may comprise asingle generally helically-shaped coil. The spring may comprise aplurality of generally helically-shaped coils. At least two of the coilscomprising the plurality of generally helically-shaped coils may beco-axially aligned. At least two of the coils comprising the pluralityof generally helically-shaped coils may be longitudinally parallelaligned. The co-axially aligned helically-shaped coils also may belongitudinally parallel aligned. The co-axially and longitudinallyparallel aligned helically-shaped coils may be helically wound withopposite winding directions relative to each other to prevent coilinterference upon compression of the coils. The system may be configuredsuch that retraction of the plunger retracts the intercoupled stoppermember and needle, such that at least a portion of the needle iswithdrawn into the interior medicine chamber of the syringe body. Theplunger may comprise a proximal thumb pad configured to facilitatemanual insertion and retraction control of the plunger relative to thesyringe body. The plunger may comprise a plunger distal end screwinterface configured to be helically inserted into the stopper memberand coupled thereto by virtue of such insertion. The plunger member maycomprise a plurality of ratchet features positioned on a surface of theplunger member, the ratchet features configured to prevent re-insertionof the plunger member relative to the syringe body after the plungermember has initially been inserted to a predetermined position relativeto the syringe body. The predetermined position may be one wherein thestopper member has been advanced to a fully-inserted position by theplunger member relative to the syringe body. The system further maycomprise a latch member operatively coupled between the plunger memberand the syringe body, wherein the latch comprises at least one ratchettooth engageable with the ratchet features, as well as a proximalinterface engageable with a handle portion of the syringe body. Thesystem further may comprise a trigger engagement member coupled to thesyringe body and configured to engage the triggering portion of thelatch member through a trigger engagement window defined through atleast a portion of the plunger member. The system further may comprise aproximal seal configured to encapsulate the stopper member within theinterior medicine chamber of the syringe body such that a vacuum load isdeveloped as the stopper is inserted into the interior medicine chamber.The system further may comprise a braking member operatively coupled tothe plunger member and the syringe body, the braking member configuredto facilitate insertion of the plunger member relative to the syringebody, but to resist retraction of the plunger member relative to thesyringe body in a first mode until the braking member has been placed ina released braking configuration second mode. The braking member maycomprise a plate-aperture brake. The plate-aperture brake may comprise apiece of sheet metal with an aperture formed therethrough. The systemfurther may comprise a spring member configured to facilitate retractionof the plunger relative to the syringe body after the plunger has beenfully inserted relative to the syringe body. The plate-aperture brakemay be configured to switch from the first mode to the second mode byinducing plastic deformation of at least a portion of the spring member.Retraction of the plunger member may be facilitated in the second modethrough application of a retraction starter load. The retraction starterload may be applied by a spring member operatively coupled to thebraking member. The retraction starter load may be applied by a springmember coupled between the plunger member and the syringe body. Thespring member may be selected from the group consisting of: a coilspring, a leaf spring, and an elastomeric spring element. The springmember may be selected from the group consisting of: a coil spring, aleaf spring, and an elastomeric spring element. The vacuum load may besufficient to at least partially retract the plunger relative to thesyringe body. Retraction of the plunger may retract the intercoupledstopper member and needle, such that at least a portion of the needle iswithdrawn into the interior medicine chamber of the syringe body. Thesystem further may comprise a needle cover member defining an innervolume configured to temporarily house and protect at least a sharpeneddistal end of the needle, while also aligning a sharpened proximal endof the needle for interfacing with the syringe body when installed by auser. The needle cover member may be removably coupled to the needlewith at least one snap-over detent interface. The needle cover membermay be removably coupled to the needle with at least two snap-overdetent interfaces. A snap-over detent interface may be oriented toprevent rotation of the needle cover member about an axis substantiallyaligned with that of the needle until the detent has been mechanicallyovercome with a torsional load. A snap-over detent interface may beoriented to prevent axial motion of the needle cover member relative tothe needle until the detent has been mechanically overcome by an axialload. The inner volume of the needle cover member may comprise aplurality internally-facing radial projection surfaces configured toguide the sharpened proximal end of the needle relative to the syringebody as the needle and syringe body are being manually intercoupled. Themedicine chamber may be defined by a chamber length, and the needle isdefined by a needle length that is equal to or longer than the chamberlength. The system further may comprise an extension member coupled to aproximal end of the syringe body, the extension member operativelycoupled to the plunger member and configured to house at least a portionof the needle when the needle is withdrawn entirely into a volumedefined by the interior medicine chamber and the extension member. Thesystem further may comprise an extension member coupled to a proximalend of the syringe body, the extension member operatively coupled to theplunger member and configured to contain the stopper member if thestopper is withdrawn to such an extent that it at least partially exitsthe interior medicine chamber, the extension member comprising a fluidcontainment surface positioned immediately adjacent the distal surfaceupon withdrawal of the stopper member into the extension chamber, thefluid containment surface configured to contain residual droplets ofmedicine which may remain coupled to the distal surface of the stoppermember until they become contained by the fluid containment surface. Theplunger member may be configured to be manually retracted by an operatorwhen the plunger latching member is in the unlatched state. The distalend of the needle may become structurally encapsulated within theinterior medicine chamber. The distal end of the needle may becomestructurally encapsulated by a needle door member movably coupled thesyringe body and be configured to have a first state wherein the needledoor member facilitates insertion of the needle relative to the syringebody, and a second state wherein the needle door member preventsinsertion of the needle relative to the syringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and a distal needleinterface; a stopper member configured to be inserted into the interiormedicine chamber to contain medicine within the medicine chamber; aplunger member configured to be manually manipulated to insert thestopper member relative to the syringe body; and a needle havingproximal and distal ends, the proximal end being removably coupled tothe distal needle interface of the syringe body and at least partiallyretractable into the interior medicine chamber upon manipulation of theplunger member relative to the syringe body to transform a plungerlatching member from a latched state to an unlatched state, the plungerlatching member slidably and rotatably intercoupled between the syringebody and the plunger member such that upon substantially full insertionof the plunger member relative to the syringe member, the plunger latchmember is axially moved and also rotated to convert from the latchedstate to the unlatched state, and also to allow the plunger member toinsert the stopper member to a full insertion position whereinsubstantially all of the contents of the interior medicine chamber maybe expelled out of the needle.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and a distal needleinterface; a stopper member configured to be inserted into the interiormedicine chamber to contain medicine within the medicine chamber; aplunger member configured to be manually manipulated to insert thestopper member relative to the syringe body using a proximalmanipulation interface; a spring member disposed within a lumen definedthrough the plunger member; a needle having proximal and distal ends,the proximal end being removably coupled to the distal needle interfaceof the syringe body and at least partially retractable into the interiormedicine chamber upon manipulation of the plunger member relative to thesyringe body to transform a plunger latching member from a latched stateto an unlatched state, the plunger latching member intercoupled betweenthe syringe body and the plunger member; wherein the plunger latchingmember is substantially disposed within the plunger member lumen andcoupled to the spring member such that the spring member is compressedmore in the latched state than it is in the unlatched state; and whereinthe proximal manipulation interface is configured to facilitate manualengagement to control a rate of plunger member retraction in theunlatched state.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and a distal needleinterface; a stopper member configured to be inserted into the interiormedicine chamber to contain medicine within the medicine chamber; aplunger member configured to be manually manipulated to insert thestopper member relative to the syringe body; and a needle having aproximal end and a sharpened distal end, the proximal end beingremovably coupled to the distal needle interface of the syringe body andat least partially retractable into the interior medicine chamber uponmanipulation of the plunger member relative to the syringe body totransform a plunger latching member from a latched state to an unlatchedstate, the plunger latching member intercoupled between the syringe bodyand the plunger member; wherein the plunger latching member issubstantially disposed within a lumen defined by the plunger member; andwherein in the unlatched state, the plunger member is at least partiallyprevented from being re-inserted relative to the syringe body by one ormore toothlike structures comprising the plunger latching member whichare configured to prevent movement of the plunger member syringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to becoupled to the stopper member, and to insert the stopper member relativeto the syringe body; and a needle having proximal and distal ends, theproximal end comprising an anchoring geometry configured to be at leastpartially inserted into the stopper member such that upon retraction ofthe stopper member, the needle is pulled proximally along with thestopper to be at least partially contained within the interior medicinechamber; wherein the stopper member defines a threaded proximalinterface, and wherein the plunger member has a distal threadedinterface configured to be helically coupled into the threaded proximalinterface of the stopper member, the distal threaded interface beingpurposely undersized relative to the threaded proximal interface of thestopper member, such that upon such helical coupling, an outer geometryof the stopper member is not substantially increased by virtue of thehelical intercoupling between the stopper member and plunger memberdistal threaded interface.

Another embodiment is directed to a system for injecting, comprising asyringe body having proximal and distal ends and defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member comprising a proximal interface configured tobe manually manipulated to move the stopper member relative to thesyringe body; a needle having a sharpened distal end; and a flangeextension member coupled to the proximal end of the syringe body, theextension member operatively coupled to the plunger member andconfigured to provide a proximal manipulation interface for the syringebody that decreases an axial compression throw distance required tocause insertion of the plunger member relative to the syringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body having proximal and distal ends and defining an interiormedicine chamber having a chamber length; a stopper member configured tobe inserted into the interior medicine chamber to contain medicinewithin the medicine chamber; a plunger member comprising a proximalinterface configured to be manually manipulated to move the stoppermember relative to the syringe body; a needle having a sharpened distalend and being defined by a needle length that is equal to or longer thanthe chamber length; and an extension member coupled to the proximal endof the syringe body, the extension member operatively coupled to theplunger member and configured to house at least a portion of the needlewhen the needle is withdrawn entirely into a volume defined by theinterior medicine chamber and the extension member.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member comprising aproximal interface and configured to be manually manipulated to insertthe stopper member relative to the syringe body; and a needle havingproximal and distal ends, the proximal end comprising an anchoringgeometry configured to be at least partially inserted into the stoppermember such that upon retraction of the stopper member, the needle ispulled proximally along with the stopper to be at least partiallycontained within the interior medicine chamber; a flange member coupledto the proximal end of the syringe body and configured to provide aproximal manipulation interface for the syringe body relative to theplunger member proximal interface; wherein the flange member comprisesan assembly of two or more parts configured to be assembled withcoupling features that are intentionally difficult to decouple, thusretaining a movably coupled state between the plunger member and thesyringe body.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber and fixedly coupledto a distally-positioned threaded Luer-lock connector; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having proximal and distal ends, the needleproximal end coupled to the Luer-lock connector using a needle couplingmember, the needle coupling member comprising a ratcheted couplingengagement relative to the Luer-lock connector such that the needlecoupling member may be easily threaded onto the Luer-lock connector withrotation in a first direction, but prevented from being uncoupled byrotation in a second direction opposite of the first direction.

Another embodiment is directed to a system for injecting, comprising asyringe body defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; a needle having proximal and distal ends, the proximal endcomprising an anchoring geometry configured to be at least partiallyinserted into the stopper member such that upon retraction of thestopper member, the needle is pulled proximally along with the stopperto be at least partially contained within the interior medicine chamber;a first imaging marker coupled to a first known location on the needle;a second imaging marker coupled to a second known location on theneedle; and an imaging system configured to detect the positions of thefirst and second imaging markers such that the orientation of the needlemay be determined relative to a global coordinate system.

Another embodiment is directed to a system for injecting, comprising asyringe body having proximal and distal ends and defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber, the stopper member comprising a distal surface configured to bedirectly interfaced with the medicine within the medicine chamber; aplunger member comprising a proximal interface configured to be manuallymanipulated to move the stopper member relative to the syringe body; aneedle having a sharpened distal end; and an extension member coupled tothe proximal end of the syringe body, the extension member operativelycoupled to the plunger member and configured to contain the stoppermember if the stopper is withdrawn to such an extent that it at leastpartially exits the interior medicine chamber, the extension membercomprising a fluid containment surface positioned immediately adjacentthe distal surface upon withdrawal of the stopper member into theextension chamber, the fluid containment surface configured to containresidual droplets of medicine which may remain coupled to the distalsurface of the stopper member until they become contained by the fluidcontainment surface.

Another embodiment of the invention is directed to a retractable safetysyringe injection system for administering to a patient injectablemedication which may be provided in a lyophilized form. The system maycomprise features for preventing inadvertent activation of a needleretraction mechanism while reconstituting or combining the lyophilizedmedicine component with a dilulent component which may be housed withina syringe body of the injection system. The system may comprise a depthstop attached to a vial adaptor component that is configured to preventinadvertent activation of the needle retraction mechanism by temporarilypreventing the latch of the retraction mechanism from moving.

Another embodiment of the invention is directed to a retractable safetysyringe injection system for administering to a patient injectablemedication which may be provided in a lyophilized form, wherein thelyophilized form of medication may be initially contained in a vial, andwherein an adaptor may be provided to couple the vial to a syringe bodycomprising the retractable safety syringe injection system such thatdilulent contained within a medicine chamber of the syringe body may besecurely mixed, such as by manually-induced shaking or agitation, withthe lyophilized medication. The lyophilized medicine vial adaptor maycomprise a clutch mechanism configured to release at a predeterminedload and/or torque to indicate to an operator that the vial adaptor andsyringe body are appropriately coupled. The clutch mechanism may beconfigured to prevent over-torquing of a syringe body luer lock ring,thereby preventing damage or dislodgement of the ring, which may causethe vial adaptor to disengage from the syringe body upon shaking oragitation. The vial adaptor may comprise an elongated shape configuredto strengthen the coupling between the syringe body and the lyophilizedmedicine vial by at least partially encapsulating the syringe body withportions of the elongated vial adaptor shape which may attach to afinger manipulation flange component coupled to or comprising a portionof the syringe body. The system may comprise a needle cover or shieldconfigured to isolate one or more portions of an injection needlemember, guide a portion of the needle member into a coupling positionrelative to the syringe body, and provide a clutch mechanism to causethe needle to be attached to a luer lock adaptor of the syringe bodywithin a predetermined torque loading window. The needle cover or shieldmay be configured to not release until a maximum predetermined torqueload is achieved. A vial adaptor, needle assembly, and dilulent filledsafe injection syringe body may be presented to an end user as a kit inone embodiment. The system may comprise a proximal mechanism configuredto prevent inadvertent activation of the needle member retractionmechanism by preventing the latch member of the retraction mechanismfrom moving until retraction may be desired.

Another embodiment of the invention is directed to a retractable safeinjection syringe system with a needle attached in a staked needleconfiguration relative to a distal portion of a syringe body. A stakedneedle assembly, needle latching mechanism, and plunger structure may beoperatively coupled with a syringe body, with the plunger structurehaving predetermined axial compliance to assist in ensuring that a fulldosage of medicine be expelled from the medicine chamber of the syringebody prior to activation of a needle retraction mechanism. Latchingmechanisms for controlling activation of the needle retraction mechanismmay comprise one or more elements configured to move away from orrelative to one or more features defined into one or more portions of aneedle assembly component to free the retraction mechanism to retractthe needle relative to the syringe body.

Another embodiment of the invention is directed to a retractable safetyneedle syringe injection system for administering to a patientinjectable medication which is provided in a lyophilized form andpresented to an operator in the form of a dual-chamber syringe body,wherein both a first medication component, such as a lyophilizedmedication component, and a second medication component, such as aliquid dilulent, are housed within the same syringe body, and which maybe mixed in preparation for injection into the patient, by operating aplunger component of the system before fully inserting the plunger toinject the mixed medicine out through a needle member distal tip intothe patient. The system may be configured to mix the two components bydelivering one component to the other through a portion of the needle,and/or around a portion of a plunger tip or stopper assembly. In oneembodiment a bypass geometry may be created into the syringe body tofacilitate passage of one component around a portion of a plunger tip orstopper assembly at a predetermined longitudinal relative positioning ofthe plunger assembly relative to the syringe body.

Another embodiment of the invention is directed to a retractable safetyneedle syringe injection system for administering to a patientinjectable medication, wherein a retraction mechanism is configured toretract a needle member substantially or completely into the confines ofthe plunger assembly. The needle member may be configured to retractinto the inner diameter of a plunger assembly housing after it isretracted through a compliant plunger tip or stopper at the distal endof the plunger assembly. A cartridge-based configuration may be utilizedto conduct an injection, wherein a re-usable housing, pen-style housingconfiguration, or auto-injector configuration is fitted around aretractable safety needle syringe injection system.

The aforementioned and other embodiments of the invention are describedin the Detailed Description which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-5C illustrate various aspects of conventional injection syringeconfigurations.

FIGS. 6A-7J illustrate various aspects of a safe injection systemconfiguration wherein a distal needle tip may be withdrawn into aprotected configuration after use.

FIGS. 8A-8P illustrate various aspects of a safe injection systemwherein a distally-disposed keyed needle and latching member interfacemay be utilized to controllably release a needle for retraction to asafe position.

FIGS. 9A-9C illustrate various aspects of a safe injection systemwherein a keyed needle and latching member interface disposed adjacentthe distal end of a syringe body medicine chamber may be utilized tocontrollably release a needle for retraction to a safe position.

FIGS. 10A-10L illustrate various aspects of a safe injection systemwherein a cantilevered latching feature may be utilized to controllablyrelease a needle for retraction to a safe position.

FIGS. 11A-11D illustrate various aspects of a safe injection systemwherein a portion of a coupling member may be controllably disrupted torelease a needle for retraction to a safe position.

FIGS. 12A-12O illustrate various aspects of a safe injection systemwherein a portion of a coupling member may be controllably dilated torelease a needle for retraction to a safe position.

FIGS. 13A-13J and 14A-14H illustrate various aspects of safe injectionsystems and portions thereof.

FIGS. 15-37 illustrate processes for conducting injection proceduresutilizing safe injection configurations such as those described inreference to FIGS. 6A-12O.

FIGS. 38A-38C illustrate various aspects of a safe injection systemconfiguration wherein a distal needle tip may be withdrawn into aprotected configuration after use.

FIGS. 39A-41F illustrate various aspects of safe injection systemconfigurations wherein a plunger and/or needle retraction mechanism maybe temporarily bypassed or disabled to facilitate movement of theplunger without actuation of the retraction mechanism.

FIG. 42 is a close up view of the structures illustrated in FIG. 41F.

FIGS. 43A-43H illustrate various aspects of a clutched vial adaptorconfiguration.

FIGS. 44A-44L illustrate various aspects of a safe mixing and injectionsystem wherein a stabilizer assembly may be utilized to assist inpreparation for injection.

FIGS. 45A-45D illustrate various aspects of needle and needle coverengagement configurations configured to prevent over-torquing.

FIG. 46 illustrates a kit configuration.

FIGS. 47A-47G illustrate various aspects of a safe injection systemwherein a cantilevered latching feature may be utilized to controllablyrelease a needle for retraction to a safe position.

FIGS. 48A-53B illustrate various aspects of safe injectionconfigurations, including but not limited to configurations which may beutilized as “staked needle” injection systems.

FIGS. 54A-58G illustrate various aspects of safe injectionconfigurations, including but not limited to configurations which may beutilized with medication components designed to be mixed to form aninjectable solution shortly before use.

FIGS. 59A-61S illustrate various aspects of safe injectionconfigurations, including but not limited to configurations wherein aneedle retraction mechanism may be substantially housed within a plungerhousing.

DETAILED DESCRIPTION

Referring to FIGS. 6A-6B, two orthogonal views of a safe injectionsystem are shown, with a conventional off-the-shelf pre-filled syringebody (34) defining a medicine chamber (40); a stopper member (36)occludes the proximal aspect of the medicine chamber, while a needleassembly (46), shown ready for injection with the distal needle tip (48)exposed, controls exit of medicine from the chamber (40) distallysubject to insertion of the plunger assembly (44) relative to thesyringe body (34) by an operator. The needle assembly (46) is removablycoupled to the syringe body (34) using a Luer interface (14), with theproximal end (50) of the needle member extending through the Luerinterface (14) and into the medicine chamber (40). A flange couplingassembly (56) comprising two mating sides configured to be difficult touncouple once forcibly coupled (i.e., by virtue of closely-tolerancedsnap fittings) is fitted to the proximal end of the syringe body (34)and provides a slidable interface for the plunger assembly (44) as it isinserted or retracted relative to the syringe body (34).

FIG. 6C illustrates an exploded view of a configuration such as thatshown in FIG. 6A, and also with the addition of a needle cover member(62) configured to be protectively coupled over the exposed distalneedle tip (48). The needle assembly (46) comprises a needle hub member(58) coupled between the proximal (50) and distal (48) needle portions.The two mating portions (52, 54) of the flange coupling assembly (56)are shown disassembled and adjacent the flange geometry (38) of theconventional syringe body (34) to which they may be coupled. The largerof the two mating portions (54) comprises a latch stop feature thatprojects inward and functions to interface with a latch configuration,as described further below. The plunger assembly (44) comprises aplunger hub member (64) that is coupled to a threaded interface (60)configured to be threaded into the compliant material (i.e., such asbutyl rubber material) that comprises the conventional stopper member(36).

FIG. 6D illustrates an exploded view of the plunger assembly (44)featuring a plunger housing member (70) featuring a plunger manipulationinterface (128), such as a thumb pad, a latch rotation housing feature(124), as described below, and an internal chamber defined to house oneor more energy-storing members, such as the two spring members (66, 68)depicted, which are configured to be coaxially disposed within theplunger housing member (70) to provide a desired springe constantperformance. The spring members (66, 68) are configured to provide aload against a latch hub member (72) that is rotatably coupled to alatching member (74) for controlled release relative to the plungerhousing member (70), as described below. When released, the latch hubmember (72) pushes against the latch stop feature of the flange couplingmember (52) to cause the stopper (36) to be retracted proximally, asdescribed below in further detail.

FIGS. 6E-6K illustrate aspects of a needle spine assembly (76),comprising the elements of the previously depicted needle assembly (46)without the needle hub assembly (58). Referring to FIG. 6E, the distalportion (48) of the needle spine assembly (76) comprises a sharpenedhypodermic needle tip formed on an injection member (78). The proximalportion (50) also comprises a sharpened tip that is formed into thecoupling member (80) that forms the distal portion. A hollow joiningmember (82) with a distal relief geometry (110) formed therein couplesthe coupling member to the tubular injection member (78). These elementsare shown in greater magnification and cross section in FIGS. 6G-6I. Inparticular, referring to the close-up cross sectional view of FIG. 6I,the intercoupling of the injection member (78), coupling member (80),and hollow joining member (82) is shown. These elements may be heldtogether with interference fits, welds, and/or adhesives. The mostproximal end of the coupling member (84) in the depicted embodimentcomprises a “harpoon” style geometry configured to stab into and holdonto a compliant member to which it may be interfaced, such as a portionof a stopper member, as described in further detail below. FIGS. 6J and6K illustrate close up views of various aspects of the coupling member,which may be formed from a thin sheet metal component using lasercutting, etching, and/or machining techniques, for example. The end ofthe coupling member (80) opposite the harpoon geometry may comprise ajoining interface (86) configured to be interference fit with a slightspring load into the joining member (82).

Referring to FIGS. 6L-6S, a needle assembly (46) comprising a needlespine assembly (76; comprising an injection member (78), joining member(82), and coupling member (80)) and needle hub assembly (58) may beinserted into an interior chamber formed within a needle cover (62)which may feature a plurality of internally facing radial projectionsurfaces (88) configured to maintain alignment of the needle assembly(46) relative to the needle cover (62) so that the needle assembly canremain housed predictably within the needle cover, and also so that theneedle assembly may be coupled to a syringe body predictably. FIG. 6Millustrates an exploded view of one embodiment of a needle hub assembly(58) to configured to at least temporarily and at least partially housethe needle spine assembly (76) while also being controllably convertibleto a configuration wherein it will prevent reinsertion of the distalneedle end (48) past the needle hub assembly (58) wherein it may beexposed and potentially reused or become dangerous. Similar to asdescribed in U.S. Patent Application Ser. No. 61/841,702, which isincorporated by reference herein in its entirety, the needle hubassembly may comprise a coupling member (96) having two bendable arms(98) configured to be interfaced with a slidable door member (94) sothat when assembled as in FIG. 6L, the needle spine assembly (76) ispassed through the proximal housing (92), through a sealing o-ring(108), through an aperture (100) formed in the coupling member (96),between the two arms (98), through an aperture (102) formed in theslidable door member (94), and through the distal housing (90). When theneedle spine assembly (76) is moved proximally relative to the needlehousing assembly (58), as soon as the distal portion (48) of theinjection member (78) has passed out of the slidable door member (94)aperture (102), the loads of the arms (98) that have been in bendingagainst sloped interface geometries (106) of the sides of the doormember (94) cause the slidable door member (106) to slide or displaceorthogonally relative to the longitudinal axis of the needle spine (76),placing a portion (104) of the door member (94) featuring a dimple ordepression, but not a clear aperture or passageway through the door, inthe pathway of the needle tip (48) should a subsequent attempt be madeto insert such needle tip (48) out past the needle hub assembly (58); inother words, the door (94) now blocks further reinsertion of the needleout past the needle hub assembly (58).

FIGS. 6N-6S illustrate interfacing of a needle assembly (46) with aneedle cover member (62). In the depicted embodiment, a plurality of luginterface features (112) are formed into the outer surface of the needlehub assembly (58) and configured to be interfaced with a plurality of“L-shaped” slots (113) with detent interface features for both insertion(114) and roll (116) such that the needle assembly (46) is inserted intothe needle cover member, is guided by the plurality of internally facingradial projection surfaces (88) engaging the needle hub assembly (58) tomaintain axial alignment of the needle cover and needle assembly (46),and then the needle hub assembly lug interface features (112) may besnapped over the detent interface features (114, 116) as they areinserted and twisted through the “L-shaped” slots (113). Such arelatively robust coupling of needle cover (62) and needle assembly (46)is configured to assist in manual coupling of the needle assembly (46)to the syringe body (34), in that the proximal portion (50) is vectoredstraight into the Luer adaptor (14) of the subject syringe body (34)with the assistance of the internally facing radial projection surfaces(88) after the needle cover (62) detent interfacing features (i.e., onefor twist, one for insertion/retraction) have been manually overcome. Inone embodiment, the detent interface geometry is specifically configured(i.e., geometrically sized and tolerance) such that the rotational loadrequired to pass the rotationally-resisting detent and remove the needlecover (62) to expose the needle is greater than or equal to therotational load required to confirm that the needle assembly has beenadequately rotationally coupled to the syringe body. Such aconfiguration provides extra confirmation that the needle assembly is,indeed, adequately coupled to the syringe body before the needle isremoved from the needle cover (62). This series of rotational and axialdetents may be used with retractable needle and hub assemblies, such asthose illustrated and described herein, or with conventional injectionsystems (i.e., on non-retractable needle and hub assemblies).

Referring to FIGS. 7A-7J, various illustrative process steps for a safeinjection system are shown. Referring to FIGS. 7A and 7B, a completesafe injection system is shown with a needle cover over the distalportion (48) of the needle assembly. The cross sectional view of FIG. 7Bshows that the spring members (66, 68) are compressed in astored-potential-energy configuration that is retained by the latch hubmember (72) as held in place by the latching member (74). Referring toFIGS. 7C and 7D, the needle cover (62) has been removed (i.e., such asby twisting, then pulling relative to the needle hub assembly toovercome the two retaining detent features described above) to exposethe needle distal portion (48) in a ready-to-inject configurationrelative to a patient. Referring to FIGS. 7E and 7F, by manipulation ofthe plunger (70) and stopper (36) relative to the syringe body (34),such as by thumb depression on the proximal plunger interface (128)combined with finger capture of the flange coupling assembly (56) thatis coupled to the syringe body (34), the contents of the medicinechamber (40) have been almost completely expelled out of the needle (48)distal tip (48). As shown in the cross sectional view of FIG. 7F, aslight bit (99) of stopper (36) insertion throw distance remains untilfull insertion of the stopper (36) and plunger (70). The spring members(66, 68) remain in the stored-potential-energy configuration, asretained by the latching member (74). Referring to FIGS. 7G and 7H, thestopper member (36) has just been completely inserted relative to thesyringe body (34) and has been stabbed by the harpoon geometry of theproximal end of the needle (50) so that the stopper (36) and needle (50)are now coupled. The latching member (74) has interfaced with the latchstop feature (126) of the flange coupling assembly (56), causing thelatching member (74) to rotate as shown (facilitated by the reliefprovided by the latch rotation housing feature 124 of the plungerhousing member 70), such that it becomes uncoupled from the latchinterface feature (122) and releases the latch hub member (72) to usethe stored potential energy of the spring members (66, 68) to apply acompressive load between the plunger housing (70) and the latch stopfeature (126) of the flange coupling assembly (56), causing the plungerhousing (70), stopper member (36), and now intercoupled needle assembly(48, 50) to be withdrawn proximally along with the plunger housing (70)such that the distal portion of the needle (48) is now safely housedwithin the medicine chamber (40) of the syringe body (34), as shown inFIGS. 7I-7J. In addition, any further attempts to advance the needle sothat the distal portion (48) thereof can be externally exposed aredefeated by the closure of the slidable door member (94) within theneedle hub assembly (58), as described above.

Referring ahead to FIGS. 13A-14H, a configuration similar to thatdescribed in reference to FIGS. 6A-7J is shown, with the exception thatthe syringe body (34) in the configurations of FIGS. 13A-14H issignificantly shorter than that of FIGS. 6A-7J. For example, in onevariation the syringe body of embodiments of FIGS. 6A-7J may be anoff-the-shelf 3 milliliter syringe body, while that of FIGS. 13A-14H maybe an off-the-shelf 1 milliliter syringe body, having a medicine chamberlength that is less than the length of the needle assembly, therebycomplicating the objective of preventing sharps danger or re-use bypositioning at least partially within the protective custody of themedicine chamber of the syringe body. As shown in FIGS. 13G-13J, asafety functionality similar to that of the embodiment of FIGS. 6A-7Jmay be accomplished using an elongated length dimension (130) of theflange coupling assembly (56; mating components 52 and 54), the lengthdimension (130) configured to accommodate proximal portions of theneedle/plunger intercoupled assembly which may need to be retracted outpast the proximal aspect of the syringe body (34) to be able to placethe distal tip of the needle (48) within the confines of the syringebody (34). Referring to FIGS. 13G and 13H, to prevent remaining dropletsof medicine previously contained within the medicine chamber (40) fromexiting the nearby vicinity, wicking surface features and geometry (132)have been formed into a surface that the stopper passes as it iswithdrawn out of the syringe body (34) and into the internal volumeformed within the flange coupling assembly (56). FIGS. 14A-14Hillustrate an injection system process that parallels that of FIGS.7A-7J, with FIGS. 14A-14B depicting a ready to use assembly with aneedle cover (62) in place; FIGS. 14C-14D illustrating the ready to useassembly with the needle cover removed and the needle distal tip (48)exposed; FIGS. 14E-14F showing full stopper member (36) insertion withthe proximal portion of the needle member (50) stabbed into and coupledto the stopper member (36)—and also the latching member (74) beingrotated by the latch stop feature (126) so that the spring members (66,68) are free to cause retraction of the plunger/stopper/needle assembly,such retraction being shown in FIGS. 14G and 14H, wherein the stoppermember (36) has been retracted past the wicking surface features andgeometry (132) to leave any residual medicine droplets contained thereas the stopper member (36) and proximal portion of the needle (50) arecontained within the internal volume formed within the flange couplingassembly (56); the slidable door member (94) has moved into a blockingposition to prevent any reinsertion of the distal portion (48) of theneedle member relative to the syringe body (34). As described above, thelength of the flange coupling assembly may be lengthened to accommodatevarious lengths of needle members relative to syringe body lengths. Theconfiguration illustrated in FIGS. 14G-14H has just enough length towithdraw the distal end (48) of the needle past the slidable door member(94) such that reinsertion may be blocked; further flange couplingassembly (56) length (130) may be included in other variations to placethe needle distal tip (49) well within the confines of the syringe body(34) at retraction of the stopper (36) and plunger (70).

While the embodiments described above in reference to FIGS. 6A-7J and13A-14H feature a spring retraction configuration, other embodiments mayavoid the spring hardware and feature retraction by manual means (suchas by retractive pulling upon the plunger manipulation interface 128),or by vacuum assisted retraction configurations, such as those describedin the aforementioned incorporated by reference application, whereby avacuum load is developed within the confines of the syringe body (34)during manual stopper insertion that may be used to assist duringretraction of the same stopper, as it pulls along portions of the needleassembly into a safe configuration.

Referring to FIGS. 8A-12O, various safe injection system configurationsare illustrated for needle/syringe body interface configurations whichmay be termed “staked needle” configurations due to the fact that ineach such configuration, a portion of the needle is supported by, or“staked” within, the conventional distal taper construct (144) (i.e.,such as a Luer taper) of the syringe body (34). These configurationsillustrate that needles may be “staked” for injection usage, and thencontrollably released from these staked intercouplings for retraction,safe storage, and re-use prevention in manners somewhat akin to those ofthe aforementioned configurations.

Referring to FIGS. 8A-8P, various aspects of a configuration forcontrollably coupling a needle into a staked configuration, andreleasing the needle from the staked configuration are shown. As shownin FIG. 8A, a needle assembly (138) may comprise a distal end (140)having a cannula-like geometry and a sharpened distal tip (152). Aradially projecting latching surface feature (148) may be formed into orfixedly coupled to the distal needle portion (140) and configured toperform a keying function in the coupling and release of the needle froma staked configuration relative to a syringe body having a distallydisposed latching member (146) as shown, wherein a keyed interfaceallows for “locking in” or “unlocking” the needle relative to thesyringe body using the radially projecting latching surface feature(148), as described in further detail below. The needle assembly (138)further may comprise a seal member (134) and loading plate (136) coupledto the proximal end of the distal needle portion (140), to which thedistal end of a proximal needle member (142) is fixedly coupled at acoupling point (152). These members are shown in uncoupled form in FIGS.8D-8G. The proximal end (142) of the needle assembly comprises a twistedsheet metal piece with harpoon proximal end features (84), the twistingintentionally configured such that a twisting moment load is stored upwhen the proximal end is inserted, or stabbed, into a compliant memberwith relative turning prevented or constrained; upon release of suchrotational constraint, the moment load creates relative rolling motion,which can be utilized to unlock the keyed interface. In other words,referring to FIGS. 8H-8J, the latching member (146) is configured sothat the distal needle member (140) may be positioned therethrough, withthe radially projecting latching surface feature (148) either in a firstposition (154), wherein retraction motion between the latching memberand radially projecting latching surface feature (148) is prevented, orrolled to a second position (156), wherein the latching member isconfigured to accommodate axial removal/withdrawal of the radiallyprojecting latching surface feature (148) through the latching member.Thus to assemble a needle assembly (138) into a staked position relativeto an off-the-shelf syringe body (34), the needle assembly (138) may beinserted through the medicine chamber (40) as shown in FIG. 8K until theseal member (134) is seated against the distal wall of the interior ofthe medicine chamber (40) of the syringe body (34); then the latchingmember may be inserted over the distal portion of the needle (140) andthe needle assembly, including the radially projecting latching surfacefeature (148), may be inserted and rotated relative to the latchingmember so that the radially projecting latching surface feature (148) isfirst passed through the fitted aperture or hole (i.e., in the secondposition described above, with the 156 position in FIG. 8I) through thelatching member (146), and then rotated to reposition the radiallyprojecting latching surface feature (148) into the locked position(i.e., in the first position described above, with the 154 position inFIG. 8I such that the needle member cannot be withdrawn relative to thelatching member 146). Such action is further illustrated, for example,in FIGS. 8N-8P. As shown in FIG. 8M, to unlock the needle assemblyrelative to the syringe body and intercoupled latching member (146), acombined loading paradigm of insertion of the needle assembly toward thesyringe body (34) along with a rotational moment to rotationally rollthe radially projecting latching surface feature (148) into the secondposition described above may be utilized, wherein the radiallyprojecting latching surface feature (148) may be withdrawn out past thelatching member (146). Thus in one embodiment, having a plunger member(70) push a stopper member (36) onto the proximal twisted end (142) ofthe needle member accomplishes three things: it builds up a moment loadfor twisting the radially projecting latching surface feature (148)relative to the latching member (146), it pushes the radially projectinglatching surface feature (148) relative to the latching member (146),and it stabs the harpoon feature of the proximal needle (142) into acoupling relationship with the stopper member (36) such that it may beretracted into a safe position, using spring-loaded, vacuum, or manualretraction means, as described above.

Referring to FIGS. 9A-9C, another keyed needle staking/unstakingconfiguration is illustrated, wherein the proximal needle portion (166)has a distal portion that comprises a keying feature (176) which may belockably/unlockably interfaced through a slot (174) formed through aloading plate (170) that is positioned between a seal member (168)configured to seal to the inner diameter of the syringe body (34), andan expansion ring (172). The locking and unlocking action as interfacedwith a stopper and plunger may be similar to that described above, withthe keyed interface being positioned internally to the syringe body (34)rather than externally, as in the embodiment of FIGS. 8A-8P.

FIGS. 10A-10L illustrate another staking/unstaking configuration for aneedle assembly relative to an off-the-shelf syringe body (34), whereina cantilevered latching feature (192) fixedly attached distally to adistal portion (182) of a needle assembly (180), with a proximal aspectfree to rotate or bend relative to the needle assembly (180), may beused for controlled unlatching with only an insertion load (i.e.,without a twisting or moment load as well, as in the aforementionedconfigurations). FIGS. 10A-10E illustrate a ready-to-use injectionsystem with a needle assembly latched in a position wherein it isconfigured to not retract when axially loaded during entry into apatient's tissue; as shown in FIG. 10F, this is due to the fact that insuch configuration, the cantilevered latching feature (192) proximal end(196) is captured in a recess (194) formed in the latching member nosepiece (190). As shown in the exploded view of FIG. 10G and detail viewsof FIGS. 10H and 101, the needle assembly (180) may comprise a distalneedle portion (182), a proximal needle portion (184), aneedle-centering bushing (202), a seal member (186; to increasecompliance, may be configured to have ribs and/or other reliefgeometries (204), as shown in FIGS. 10J and 10K), and a loading plate(186) configured to be interfaced with a stopper (36) coupled to aplunger member (70), as shown in FIG. 10G. Also shown in FIG. 10G is thelatching member nose piece (190), an occlusion element (201), and a capmember (200). In system assembly, the needle assembly (180) may beinserted through the off-the-shelf syringe body (34) as shown in FIG.10G, with the needle distal end (182) threaded through the distal end(144) of the syringe body (34) and the proximal end (196) of thelatching feature (192) exposed (it preferably is biased to bend towardthe needle distal end 182 into a “flush” configuration for retraction);then the latching feature (192) distal end (196) may be bent outward andfitted into the recess (194) of the latching member nose piece (190),followed by threading of the occlusion element (201) and cap member(200) over the needle distal portion (182), to result in a construct asshown in FIG. 10F. Upon full insertion of a plunger to push the stoppermember against the loading plate (188), the needle assembly (180) isinserted just enough to allow the distal end (196) of the latchingfeature (192) to come out of the recess (194) and snap into the flushposition against the needle member (182), which allows the needleassembly (180) to be withdrawn into a safe position relative to thesyringe body (34), such as by a spring-loaded mechanism, vacuum loadassisting, or manual retraction, as described above. With retraction ofthe distal tip of the needle distal portion (182) past the occlusionmember (201), the occlusion member (201) is configured to become free tomove/reorient around inside of the small compartment containing theocclusion member (201), such that it would be quite difficult to realignsuch occlusion member (201) to allow re-insertion of the needle distalportion (182) past this occlusion member (201); thus the occlusionmember (201) functionally occludes the distal needle passageway andfunctions somewhat akin to the aforementioned slidable door member (94)in preventing reexposure of the needle.

Referring to FIGS. 11A-11D, in another embodiment, one or morestructural and/or sealing members may be altered to release a needlefrom a staked configured to an unstaked configuration wherein it may bewithdrawn to a safe position. As shown in FIG. 11A, a needle assemblymay comprise a distal portion (218), and a proximal portion (216)coupled to one or more sealing and/or structure members (208, 206)configured to fixedly hold the needle assembly in a staked configurationduring injection of medicine into a patient, and then at a fullinsertion position of the stopper member (36) and plunger (70) relativeto the syringe body (34), to release the grasp of the one or moresealing and/or structural members (208, 206) such that the needle membermay be withdrawn proximally, leaving the one or more sealing and/orstructural members (208, 206) behind. As shown in the cross sectionaldepiction in FIG. 11B, the needle is in a staked configuration, readyfor injection. As shown in FIG. 11C, with the stopper member (36) fullyinserted relative to the syringe body (34), the sealing member (208)remains intact, but a portion of the needle assembly fractures or cuts aportion of the composite stabilizing member (206; here comprising acompliant sealing/grasping portion 212 and a more rigid structuralportion 210), such as the sealing/grasping portion 212, causing theneedle to be axially released relative to the stabilizing member (206),so that it may be retracted (such as is shown in FIG. 11D) into a safeposition relative to the syringe body (34), such as by a spring-loadedmechanism, vacuum load assisting, or manual retraction, as describedabove.

Referring to FIGS. 12A-12O, an embodiment somewhat similar to that ofFIGS. 11A-11D is illustrated, wherein a sealing/grasping grommet member(222) is dilated by a dilator portion (234) of a spacer/dilator assembly(232) that is coupled to a needle assembly (224), the dilationconverting the grommet from a gripping stabilizing configuration thatholds the needle assembly (224) in a “staked” type of configuration forpatient injection usage, to an “unstaked” configuration wherein theneedle assembly (224) may be withdrawn, such as in FIGS. 12M-12O, into asafe position relative to the syringe body (34), such as by aspring-loaded mechanism, vacuum load assisting, or manual retraction, asdescribed above. FIGS. 12A, 12C, and 12D-12F illustrate a safe injectionsystem ready to use, FIG. 12A also showing a protective needle cap (220)over the needle before use. As shown in FIGS. 12B, 12E, and 12F, theneedle assembly (224), comprising a proximal end (226) featuring aharpoon configuration (84), a sharpened distal end (228) for injectioninto a patient, and a coupling collar (230) to couple the proximal anddistal ends, may be inserted through a spacer/dilator assembly (232)featuring a spacer member (238) coupled to a dilator tube (234) by acoupling collar (240); the spacer may be fixedly held against the distalend (144) of the syringe body (34) using a snap ring (236), the needleassembly being slidable through the interior of the spacer/dilatorassembly (232) but for the grasping of the grommet member (222) upon theproximal portion (226) of the needle member around the location labelled“223” in FIG. 12F. This grasping is configured to be substantial enoughto withstand conventional injection-into-tissue loads, thus placing theneedle into a “staked” configuration relative to the syringe body (34).FIGS. 12G-12I illustrate that a plunger and stopper may be inserted toinject medicine into the patient through the injection lumen (244).Referring to FIGS. 12J-12L, with further insertional loading of theplunger and stopper (36) to a fully-seated configuration as shown indetail in FIG. 12L, the dilator tube (234) is advanced across whatpreviously was the grasping region (i.e., as in FIG. 12F), so that theneedle is now free to be retracted relative to the spacer/dilatorassembly and syringe body, into a safe position relative to the syringebody (34), such as by a spring-loaded mechanism, vacuum load assisting,or manual retraction, as described above, as shown in FIGS. 12M-12O.

Suitable polymeric materials for the various components of theseembodiments include but are not limited to acetal, polycarbonate, polyvinyl chloride, polypropylene, polystyrene, ABS, nylon, glass-fillednylon, glass-filled acetal, peek, glass-filled peek, carbon-fiber-filledpeek, COC (cyclic olefin copolymer), COP (cyclic olefin polymer), PEI(Ultem), glass-filled PEI, and pekk, as well as copolymers thereof.

Suitable structural metals for structures such as the plunger insertionmember include but are not limited to stainless steel, steel with chromecoating, brass, nickel, and titanium, as well as alloys thereof.

Suitable needle member sizes range from about 34 gauge/6 millimeterslong—to about 20 gauge/2.5 inches long.

Referring to FIGS. 15-37, processes for conducting injection proceduresutilizing safe injection configurations such as those described inreference to FIGS. 6A-12O are illustrated.

Referring to FIG. 15, one method may comprise providing (302) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; and a needlehaving proximal and distal ends, the proximal end comprising ananchoring geometry; and (304) at least partially inserting the anchoringgeometry of the needle into the stopper member such that upon retractionof the stopper member, the needle is pulled proximally along with thestopper to be at least partially contained within the interior medicinechamber.

Referring to FIG. 16, one method may comprise providing (306) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; a needle havingproximal and distal ends; and a coupling member operatively coupled tothe syringe body and needle; and (308) moving the coupling memberbetween a first state, wherein the needle is removably coupled to thesyringe body, to a second state, wherein the needle is free to retractrelative to the syringe body; and (310) moving the coupling member to athird state wherein the needle is mechanically prevented from furtherinsertion relative to the syringe body.

Referring to FIG. 17, one method may comprise providing (312) aninjecting assembly comprising a syringe body defining an interiormedicine chamber and a distal needle interface; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having proximal and distal ends, the proximalend configured to be coupled to the stopper member upon insertion of thestopper member to a fully-inserted position, such that upon retractionof the stopper member, the needle is pulled proximally along with thestopper to be contained within the interior medicine chamber; and (314)upon retraction of the needle into the interior medicine chamber to aposition wherein the distal end of the needle is contained within theinterior medicine chamber, misaligning the needle with a longitudinalaxis of the syringe body such that it is prevented from being reinsertedout of the interior medicine chamber; and (316) configuring the needleto plastically deform (such as by bending of at least one portion of theneedle) upon attempt to re-insert the needle relative to the syringebody after the needle becomes misaligned with a longitudinal axis of thesyringe body.

Referring to FIG. 18A, one method may comprise providing (318) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; a needle havinga sharpened distal end; and a needle door member movably coupled thesyringe body; and (320) moving the needle door member from a first statewherein the needle door member facilitates insertion of the needlerelative to the syringe body, to a second state wherein the needle doormember prevents insertion of the needle relative to the syringe body;and (322) slidably moving the needle door member in a plane relative tothe longitudinal axis of the needle (such as a plane that issubstantially perpendicular relative to the longitudinal axis of theneedle).

Referring to FIG. 18B, one method may comprise providing (318) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; a needle havinga sharpened distal end; and a needle door member movably coupled thesyringe body; and (320) moving the needle door member from a first statewherein the needle door member facilitates insertion of the needlerelative to the syringe body, to a second state wherein the needle doormember prevents insertion of the needle relative to the syringe body;and (324) rotating the needle door member relative to the longitudinalaxis of the needle (such as about an axis of rotation that substantiallyintersects, or does not intersect, the longitudinal axis of the needle).

Referring to FIG. 19, one method may comprise providing (326) aninjecting assembly comprising a syringe body defining an interiormedicine chamber and a distal needle interface defining a Luer taper; astopper member configured to be inserted into the interior medicinechamber to contain medicine within the medicine chamber, the stoppermember having proximal and distal ends; a plunger member configured tobe manually manipulated to insert the stopper member relative to thesyringe body; and a medicine cap removably coupled to the distal needleinterface and configured to seal the interior medicine chamber; and(328) removing the medicine cap; and (330) removably coupling a needleto the syringe body, the needle having proximal and distal ends, theproximal end comprising a coupling portion configured to be removablycoupled to an external surface of the Luer taper after the medicine caphas been removed, and a retraction portion configured to become coupledto the stopper member such that upon withdrawal of the stopper memberrelative to the syringe body, the needle may be withdrawn relative tothe syringe body.

Referring to FIG. 20, one method may comprise providing (332) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; a needle havingsharpened proximal and distal ends; and a needle cover member definingan inner volume configured to temporarily house and protect at least asharpened distal end of the needle; and (334) utilizing the needle covermember to align a sharpened proximal end of the needle for interfacingwith the syringe body as the two are interfaced by a user.

Referring to FIG. 21, one method may comprise providing (336) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; a needle havingsharpened proximal and distal ends; and a needle cover member definingan inner volume configured to temporarily house and protect at least asharpened distal end of the needle; and (338) removably coupling theneedle cover member and the needle with at least one snap-over detentinterface, such as one detent interface oriented to prevent relativerotation of the needle and needle cover, and one detent interfaceoriented to prevent relative insertion/retraction of the needle andneedle cover; and (340) using the needle cover member to align thesharpened proximal end of the needle for interfacing with the syringebody as the two are coupled by a user.

Referring to FIG. 22, one method may comprise providing (342) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; and a needlehaving proximal and distal ends and an air bubble exit lumen definedtherebetween, the air bubble exit lumen comprising an entry port definedinto the needle and positioned immediately adjacent a distal end of themedicine chamber; and (344) expelling air bubbles within the chamberwith insertion of the stopper member regardless of the level ofprotrusion of the proximal end of the needle into the medicine chamber.

Referring to FIG. 23, one method may comprise providing (346) aninjection assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; and a needlehaving sharpened proximal and distal ends; a distal seal element havingproximal and distal ends and being sealably disposed within the medicinechamber, the distal seal element being releasably couplable to theneedle proximal end such that a sealed interface may be providedtherebetween; and (348) in a first coupled mode, positioning thesharpened proximal end of the needle at least partially through thedistal seal element such that the distal seal element grips onto theneedle proximal end; and (350) in a second release mode, using adilating element to dilate the interface between the distal seal elementand the sharpened proximal end of the needle such that the needlebecomes releasable from the distal seal element; and (352) coupling(such as by having the sharpened needle proximal end comprise ananchoring geometry configured to be at least partially inserted into thestopper member) the sharpened needle proximal end to the stopper member,such that upon retraction of the stopper member, the needle is pulledproximally along with the stopper to be at least partially containedwithin the interior medicine chamber; and (354) advancing the plungerrelative to the syringe body to forcibly expel medicine from theinterior medicine chamber out through the distal end of the needle.

Referring to FIG. 24, one method may comprise providing (356) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; a needle havingsharpened proximal and distal ends; a distal seal element removablycoupled around at least a portion of the proximal end of the needle andconfigured to grip onto the proximal end of the needle until dilatedaway therefrom; and a dilating element coupled to the needle proximalend; and (358) dilating the distal seal element away from the proximalend of the needle with the dilating element to release the needle fromthe distal seal element by advancement of the distal seal element towardthe dilating element while the dilating element and intercoupled needleremain substantially stationary relative to the syringe body; and (360)coupling (such as by having the sharpened needle proximal end comprisean anchoring geometry configured to be at least partially inserted intothe stopper member) the sharpened needle proximal end to the stoppermember, such that upon retraction of the stopper member, the needle ispulled proximally along with the stopper to be at least partiallycontained within the interior medicine chamber; and (362) advancing theplunger relative to the syringe body to forcibly expel medicine from theinterior medicine chamber out through the distal end of the needle.

Referring to FIG. 25, one method may comprise providing (364) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; a needle havingproximal and distal ends, the proximal end coupled to a distal end ofthe syringe body; and a needle sheath operatively coupled to the syringebody and defining a lumen through which at least the distal end of theneedle may be passed, the needle sheath configured to have a firststate, wherein the needle sheath is compressed toward the proximal endof the needle to expose the distal end of the needle for injecting, anda second state, wherein the needle sheath is advanced forward over theneedle distal end to substantially cover the needle and prevent contactwith the distal end of the needle; wherein in the first state, an energystorage member (such as a spring) is compressed to bias the needlesheath to spring forward into the second state but for a sheathretention element which retains the needle sheath in the first positionuntil the stopper member has been advanced to a predetermined positionrelative to the syringe body (such as one wherein the stopper member hasbeen advanced to a maximum advancement position relative to the syringebody; at the predetermined position, the plunger may apply a loadagainst the needle, which may release the sheath retention element); and(366) advancing the stopper member into the predetermined positionrelative to the syringe body to cause the needle sheath to be advancedforward over the needle distal end; and (368) using a sheath-limitingmember to restrain the needle sheath from advancing in the second statepast a predetermined axial extension position relative to the syringebody.

Referring to FIG. 26, one method may comprise providing (370) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; a needle havingproximal and distal ends, the proximal end coupled to a distal end ofthe syringe body; and a telescoping needle sheath operatively coupled tothe syringe body and defining a lumen through which at least the distalend of the needle may be passed, the needle sheath configured to have afirst state, wherein the telescoping needle sheath is telescopicallycompressed toward the proximal end of the needle to expose the distalend of the needle for injecting, and a second state, wherein the needlesheath is telescopically advanced forward over the needle distal end tosubstantially cover the needle and prevent contact with the distal endof the needle; wherein in the first state, an energy storage member(such as a spring) is compressed to bias the needle sheath to springforward into the second state but for a sheath retention element whichretains the needle sheath in the first position until the stopper memberhas been advanced to a predetermined position relative to the syringebody (such as one wherein the stopper member has been advanced to amaximum advancement position relative to the syringe body; at thepredetermined position, the plunger may apply a load against the needle,which may release the sheath retention element); and (372) advancing thestopper member into the predetermined position relative to the syringebody to cause the needle sheath to be telescopically advanced forwardover the needle distal end; and (374) using a sheath-limiting member torestrain the needle sheath from advancing in the second state past apredetermined axial extension position relative to the syringe body.

Referring to FIG. 27, one method may comprise providing (376) aninjecting assembly comprising a syringe body defining an interiormedicine chamber and a distal needle interface comprising a Luer taperdefining an inner surface that is fluidly coupled to the interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; and a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; and (378)coupling a needle having proximal and distal ends to the syringe body,such that the proximal end of the needle is removably attached to theinner surface of the Luer tapere of the syringe body; and (380)advancing the plunger relative to the syringe body to forcibly expelmedicine from the interior medicine chamber out through the distal endof the needle.

Referring to FIG. 28, one method may comprise providing (382) aninjecting assembly comprising a syringe body defining an interiormedicine chamber and a distal needle interface; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; a needle having proximal and distal ends, the proximal endremovably attached to the syringe body distal needle interface; and aneedle seal operatively coupled between the needle and distal needleinterface, the needle seal configured to prevent fluid flow between anouter surface of the needle and the distal needle interface; and (384)coupling the needle to at least one radially-projecting latchingfeature, the latching feature configured to interface with a mechanicallatch to prevent axial movement of the needle relative to the syringe ina latched configuration, and to facilitate movement of the needle of theneedle relative to the syringe body in an unlatched configuration; and(386) advancing the plunger relative to the syringe body to forciblyexpel medicine from the interior medicine chamber out through the distalend of the needle.

Referring to FIG. 29, one method may comprise providing (388) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; and a needlehaving proximal and distal ends, the proximal end comprising ananchoring geometry configured to be at least partially inserted into theplunger member such that upon retraction of the plunger member, theneedle is pulled proximally to be at least partially contained withinthe interior medicine chamber; and (390) retracting the plunger memberto leave the needle at least partially contained within the interiormedicine chamber; and (392) removably coupling the stopper to theplunger member such that upon insertion to a fully inserted positionrelative to the syringe body, the stopper remains in place while theplunger member may be retracted to retract the needle.

Referring to FIG. 30, one method may comprise providing (394) aninjecting assembly comprising a syringe body defining an interiormedicine chamber and a distal needle interface; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having proximal and distal ends, the proximalend being removably coupled to the distal needle interface of thesyringe body and at least partially retractable into the interiormedicine chamber; and (396) manipulating the plunger member relative tothe syringe body to transform a plunger latching member from a latchedstate to an unlatched state, the plunger latching member intercoupledbetween the syringe body and the plunger member, wherein the plungerlatching member is substantially disposed within a lumen defined by theplunger member.

Referring to FIG. 31, one method may comprise providing (398) aninjecting assembly comprising a syringe body defining an interiormedicine chamber and a distal needle interface; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having proximal and distal ends, the proximalend being removably coupled to the distal needle interface of thesyringe body and at least partially retractable into the interiormedicine chamber; and (400) manipulating the plunger member relative tothe syringe body to transform a plunger latching member from a latchedstate to an unlatched state, the plunger latching member slidably androtatably intercoupled between the syringe body and the plunger membersuch that upon substantially full insertion of the plunger memberrelative to the syringe member, the plunger latch member is axiallymoved and also rotated to convert from the latched state to theunlatched state, and also to allow the plunger member to insert thestopper member to a full insertion position wherein substantially all ofthe contents of the interior medicine chamber may be expelled out of theneedle.

Referring to FIG. 32, one method may comprise providing (402) providingan injecting assembly comprising a syringe body defining an interiormedicine chamber and a distal needle interface; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body using a proximal manipulation interface; a spring memberdisposed within a lumen defined through the plunger member; a needlehaving proximal and distal ends, the proximal end being removablycoupled to the distal needle interface of the syringe body and at leastpartially retractable into the interior medicine chamber; and (404)manipulating the plunger member relative to the syringe body totransform a plunger latching member from a latched state to an unlatchedstate, the plunger latching member intercoupled between the syringe bodyand the plunger member; wherein the plunger latching member issubstantially disposed within the plunger member lumen and coupled tothe spring member such that the spring member is compressed more in thelatched state than it is in the unlatched state; and wherein theproximal manipulation interface is configured to facilitate manualengagement to control a rate of plunger member retraction in theunlatched state.

Referring to FIG. 33, one method may comprise providing (406) aninjecting assembly comprising a syringe body defining an interiormedicine chamber and a distal needle interface; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber; a plunger member configured to bemanually manipulated to insert the stopper member relative to thesyringe body; and a needle having a proximal end and a sharpened distalend, the proximal end being removably coupled to the distal needleinterface of the syringe body and at least partially retractable intothe interior medicine chamber; and (408) manipulating the plunger memberrelative to the syringe body to transform a plunger latching member froma latched state to an unlatched state, the plunger latching memberintercoupled between the syringe body and the plunger member; whereinthe plunger latching member is substantially disposed within a lumendefined by the plunger member; and wherein in the unlatched state, theplunger member is at least partially prevented from being re-insertedrelative to the syringe body by one or more toothlike structurescomprising the plunger latching member which are configured to preventmovement of the plunger member syringe body.

Referring to FIG. 34, one method may comprise providing (410) providingan injecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be coupled to the stoppermember, and to insert the stopper member relative to the syringe body;and a needle having proximal and distal ends, the proximal endcomprising an anchoring geometry configured to be at least partiallyinserted into the stopper member; and (412) retracting the stoppermember to pull the needle proximally along with the stopper to be atleast partially contained within the interior medicine chamber; whereinthe stopper member defines a threaded proximal interface, and whereinthe plunger member has a distal threaded interface configured to behelically coupled into the threaded proximal interface of the stoppermember, the distal threaded interface being purposely undersizedrelative to the threaded proximal interface of the stopper member, suchthat upon such helical coupling, an outer geometry of the stopper memberis not substantially increased by virtue of the helical intercouplingbetween the stopper member and plunger member distal threaded interface.

Referring to FIG. 35, one method may comprise providing (414) aninjecting assembly comprising a syringe body having proximal and distalends and defining an interior medicine chamber having a chamber length;a stopper member configured to be inserted into the interior medicinechamber to contain medicine within the medicine chamber; a plungermember comprising a proximal interface configured to be manuallymanipulated to move the stopper member relative to the syringe body; aneedle having a sharpened distal end and being defined by a needlelength that is equal to or longer than the chamber length; and anextension member coupled to the proximal end of the syringe body, theextension member operatively coupled to the plunger member; and (416)withdrawing the needle entirely into a volume defined by the interiormedicine chamber and the extension member; and (418) housing at least aportion of the needle within the extension member.

Referring to FIG. 36, one method may comprise providing (420) aninjecting assembly comprising a syringe body defining an interiormedicine chamber; a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; a needle havingproximal and distal ends, the proximal end comprising an anchoringgeometry configured to be at least partially inserted into the stoppermember such that upon retraction of the stopper member, the needle ispulled proximally along with the stopper to be at least partiallycontained within the interior medicine chamber; a first imaging marker(such as a metallic bead, metallic ring, or a radiation-emitting beacon)coupled to a first known location on the needle; and a second imagingmarker (such as a metallic bead, metallic ring, or a radiation-emittingbeacon) coupled to a second known location on the needle; and (422)utilizing an imaging system to detect the positions of the first andsecond imaging markers such that the orientation of the needle may bedetermined relative to a global coordinate system.

Referring to FIG. 37, one method may comprise providing (424) aninjecting assembly comprising a syringe body having proximal and distalends and defining an interior medicine chamber; a stopper memberconfigured to be inserted into the interior medicine chamber to containmedicine within the medicine chamber, the stopper member comprising adistal surface configured to be directly interfaced with the medicinewithin the medicine chamber; a plunger member comprising a proximalinterface configured to be manually manipulated to move the stoppermember relative to the syringe body; a needle having a sharpened distalend; and an extension member coupled to the proximal end of the syringebody, the extension member operatively coupled to the plunger member andconfigured to contain the stopper member if the stopper is withdrawn tosuch an extent that it at least partially exits the interior medicinechamber; and (426) withdrawing at least a portion of the stopper memberinto the extension member; and (428) containing residual droplets ofmedicine which may remain coupled to the distal surface of the stoppermember until they become contained by a fluid containment surface (suchas one that defines one or more fluted geometries configured to retainthe residual droplets and/or defines one or more perforations configuredto retain the residual droplets) positioned immediately adjacent thedistal surface upon withdrawal of the stopper member into the extensionchamber; an absorbant member may be fluidly coupled to the fluidcontainment surface, the absorbant member configured to absorb andretain the residual droplets.

Referring to FIGS. 38A-38C, an embodiment is shown wherein a needleassembly (502) is removably coupleable to a syringe body (34) in astaked needle configuration somewhat akin to that described in referenceto FIGS. 8A-8P, with the exception that the embodiment of FIGS. 38A-38Cis releasably coupled to the distal end (144) of the syringe body (34)through the use of a mechanical block member (506) that is fixedlycoupled to bent-shaped needle member (504). Referring to FIG. 38A, in aready-to-use (i.e., inject medicine into a patient) configuration, theneedle assembly is held in place by the mechanical interfacing of theblock member (506) and a distal surface (516) of the syringe body (34)end (144). When the plunger (not shown) is fully inserted, it presents acompressive load against a spring member (510), here a star-shapedconfiguration to provide a desired spring constant, which ultimatelyinserts the bent needle member (504) distally relative to the syringebody (34) end (144) by a distance large enough to decouple the blockmember (506) from the distal surface (516) of the syringe body (34) end(144), thereby allowing the bent needle member (504) to freely deflectto its unloaded position whereby the block member is free to slipthrough the aperture of the syringe body (34) end (144) so that theneedle may be retracted along with retraction of the plunger, such as bya harpoon interface as described above, wherein the harpoon-shaped (84)proximal end (512) of the needle member is stabbed into and coupled tothe plunger member so that the distal tip of the needle member (514) maybe withdrawn into a safe configuration by the plunger member whereby itis shielded by the syringe body (34). FIG. 38C illustrates an explodedview of the aforementioned components.

Referring to FIGS. 39A-41F, configurations are presented that allow forthe plunger to be fully or almost fully inserted relative to a syringebody without triggering the needle-withdrawing latching mechanismdescribed above. This may be useful in scenarios wherein it is useful tofirst expel the contents of the medicine chamber (40) by inserting theplunger member, then retract the plunger member to re-fill the medicinechamber, only to finally insert the plunger member to conduct aninjection into a patient, after which needle retraction is desired. Onesuch scenario involves the use of lyophilized, or freeze-dried,medications. In certain lyophilized medication scenarios, one portion ofthe medication is supplied in a powder form in a vial, while anotherportion of the medication is supplied in liquid form, such as in apre-filled syringe body. The configurations described herein inreference to FIGS. 39A-41F may be utilized to a) couple the syringe bodyto an external lyophilized medicine vial; b) facilitate injection of theliquid contents of the syringe body medicine chamber into the externallyophilized medicine vial by insertion of the plunger member relative tothe syringe body, such that the liquid and powdered contents may becombined and/or mixed in the external vial; c) facilitate introductionof the mixed medicine contents from the external via into the medicinechamber of the syringe body by retraction of the plunger; d) facilitatedecoupling of the external vial from the syringe body and coupling of aninjection needle assembly in its place; e) facilitate injection of themixed medicine contents of the medicine chamber into the patient throughthe needle, followed by retraction of the needle into a safeconfiguration relative to the syringe body, as described above. Insimplified, terms, such configurations allow the plunger to be insertedand retracted without triggering the automatic needle retractionmechanisms, until such retraction is desired (generally after the actualinjection stroke to expel the medicine from the medicine chamber,through the needle member, and into the patient).

Referring to FIGS. 39A-39B, a vial adaptor assembly (518) is depictedwhich comprises an external vial adaptor cap (520) coupled to asharpened medicine retrieval interface (522) configured to stab througha seal of an external medicine vial to gain access to the associatedmedicine. The proximal end of the assembly (518) comprises a Luerinterface (524) configured to be removably coupled to a similarinterface of the syringe assembly, and fixedly coupled through the Luerinterface (524) is a plunger insertion stop member (526) which isconfigured to prevent full insertion of the plunger of the associatedsyringe assembly—which prevents full function of the associated latchingmechanism, which, in turn, prevents retraction of the plunger asdescribed above. Referring to FIGS. 40A-40C, a sequence is illustratedwherein a vial adaptor assembly (518) is coupled, using Luerinterfacing, to the distal end of the needle assembly to allow for theplunger (36) of the needle assembly to be inserted (as shown in FIG.40B) without activating the plunger/needle retraction mechanism. Theplunger may then be retracted to bring the combined medicine into thesyringe body (34) medicine chamber (40), after which the vial adaptorassembly (518) may be removed and replaced with a needle assembly (46),as shown in FIG. 40C, such that the combined medicine may be injectedinto a patient, followed by retraction of the plunger and needle memberas described above using the pertinent retraction mechanism.

Referring to FIGS. 41A-41F, in another embodiment, rather than blockingfull insertion of the plunger relative to the syringe body to preventretraction actuation, as described above in reference to FIGS. 39A-40C,retraction actuation may be temporarily prevented by preventing movement(i.e., preventing rotation of a latching member 74 relative to theplunger housing 70 or latch rotation housing feature 124) of thelatching/retraction componentry. FIGS. 41A-41C illustrate differentlyzoomed in views of an assembly similar to that of FIG. 7B, but with adifferent proximal interface assembly (528) that comprises a latchrotation blocking member (532) configured to prevent rotation of thelatching member (74) relative to the plunger housing 70 or latchrotation housing feature 124 upon initial insertion. Referring to FIG.41D, a close in view is shown wherein the latch rotation blocking member(532) extends distally toward the latch member (74); with fullinsertion, this latch rotation blocking member (532) fits into the latchrotation housing feature 124 and prevents rotation of the latch member(74), thereby preventing the plunger retraction mechanism from beingtriggered. When the outer housing member (530) of the proximal interfaceassembly (528) is tensioned relative to the syringe body or plungerhousing (70), a spring plate (534), which is fixedly coupled to thelatch rotation blocking member (532), moves into a movably-coupledconfiguration relative to the outer housing member (530) whichfacilitates motion of the latch rotation blocking member (532) that issufficient to prevent it from becoming a mechanical block to rotation ofthe latch member (74) relative to the plunger housing 70 or latchrotation housing feature 124. In other words, after the spring plate(534) has moved to the movably coupled configuration relative to theouter housing member (530), the latching mechanism and full retractionof the plunger member (36) and needle member via the spring (68) shallbe in operation as described above in relation to FIGS. 7A-7J, forexample. FIGS. 41E and 41F show the outer housing member removed toillustrate the spring plate (534) with plurality of spring members (536)configured to be engaged against the inside of the outer housing memberbefore the spring plate (534) has moved to the movably coupledconfiguration relative to the outer housing member (530). FIG. 42illustrates a close-in view of a portion of the structures illustratedin FIG. 41F.

Referring to FIGS. 43A-43H, various aspects of a vial adaptor assemblyconfiguration are illustrated, wherein a clutched Luer configurationprevents over-torquing of the vial adaptor and associated vial relativeto a syringe body (34) during preparation for injection. Referring toFIGS. 43A and 43B, a vial adaptor assembly may be delivered in anencapsulating housing or cover (552) which features a removable seal(554). Referring to FIGS. 43C and 43D, with the cover removed, the vialadaptor assembly (556) is visible, comprising a vial coupling cap (521)configured to provide a snap fit with the exterior features of astandard vial (560), as shown in FIGS. 43E and 43F. A sharpened medicineretrieval interface (522) is configured to stab into an integrated sealon a vial (560) to provide an intercoupled syringe body with access tothe medicine within the vial (560). Another vial adaptor configurationis described above in reference to FIGS. 39A-39B with a Luer interface(524) that is substantially fixed relative to the vial adaptor couplingcap (520—see, for example, FIG. 39B). The vial adaptor assembly (556)illustrated in FIGS. 43A-43H features a Luer interface (524) with aclutched rotatable coupling interface (558) relative to the vial adaptorcoupling cap (521), which is configured to prevent over-torquing of thevial adaptor cap (521) relative to the syringe body (34 —see, forexample, FIG. 43H), such as torques which may be passed across a Luerlock ring or fitting (14) which may be coupled to the syringe body (34).In the case of select glass or plastic bodied syringe bodies, the luerlock ring or fitting (14, 18) may be coupled to the male luer feature ofthe syringe body via a snap-fit connection. Over-torquing of the ringduring assembly of devices to the syringe may twist the luer lock ringrelative to the syringe body, and such twisting may loosen the snap-fitconnection of the luer lock ring, preventing future devices from beingattached securely to the syringe body. As shown in FIG. 43G, in oneembodiment, a plurality of clutch ramp interface features (562) areformed into the inner surface of the vial adaptor cap (521) andconfigured to engage with a plurality of protruding features on theperimeter of the Luer interface member, such that after a predeterminedamount of torque is applied at the interface, the protruding featureswill move over the clutch ramp interface features (562), allowing theinterface to effectively freewheel forward rotationally until the nextramp/protrusion interface becomes engaged. This engagement provides fora clutching configuration whereby after a maximum torque is reached, theinterface will roll and effectively release the torque until furtheradvancement to the next ramp/protrusion interfacing configuration isreached. Preventing torque beyond such a predetermined maximum isbelieved to prevent accidental removal or fracturing of other portionsof the overall assembly, such as the press-fit interface between theLuer assembly of the syringe body and the syringe body itself.

Referring to FIGS. 44A-44L, various aspects of stabilizingconfigurations are illustrated, which feature a stabilizer assemblydesigned to mechanically stabilize an assembly of various componentswhen they are being rapidly oscillated in space (such as in the casewhen it is desirable to use an operator's hand to agitate suchcomponents to mix medicine which may be contained therein, as describedabove in reference to multi-component injection medicine configurations,such as those featuring lyophilized drugs, wherein a powder may need tobe mixed with a liquid before injection). Referring to FIG. 44A, adistal end of the depicted stabilizer assembly (570) comprises a vialadaptor coupling cap portion (568) which may closely resemble thosefeatured, for example, in FIGS. 43C and 43D, which is fixedly coupled toa main tubular shaft portion (576) which may have one or morevisualization windows (566) defined therethrough so that the syringebody (34) may be viewed. The proximal end of the depicted stabilizerassembly (570) comprises a rotatable coupling interface (572) configuredto be threadably coupled to one or more coupling features (573) on theflange coupling assembly (56). The one or more coupling features (573)may comprise a rotational snap over detent (575) to provide a tactileand/or audible indication the operator when a proper connection has beenachieved. To create the necessary spring force for the detent (575), theproximal end of the stabilizer assembly (572) may define cut-outportions (see, for example, FIG. 44I) to make the shaft of thestabilizer assembly axially extensible in the region adjacent to thethreaded interface (572). Other rotational detent configurations mayalso be employed in this vial adapter device. Radial projecting detentssuch as those described herein with reference to the needle assembly andneedle cover may be applied to this coupling interface as well. In oneembodiment, the threadibly coupled interface between the vial stabilizer(570) and the syringe body (34) also may be configured to indicate tothe operator when the connection is not properly connected. If theoperator screws the interface together and does not snap over thedetent, the thread pitch of the threadable connection may be configuredto be large enough to eject the vial stabilizer (570) back away from thesyringe. This indicates to the operator to re-connect the interface. Asshown in FIG. 44I, the distal end of the vial adaptor coupling capportion (568) may have an oval or noncircular flange geometry (578) toprevent the assembly from rolling when placed on a flat surface such asa table. FIG. 44B (and cross sectional FIGS. 44C and 44D) illustrate anassembly with a medicine vial (560) engaged, along with a syringe body(34), in a substantially stable configuration designed to be safelyshaken by hand without damaging or accidentally decoupling componentsthereof. A flexible seal component (574) provides a flexible interfacewhich may be compressed or expanded with coupling engagement to passfluids between the vial (560) and the syringe body (34). Alternatively,the seal between the vial stabilizer coupling cap portion (568) and thesyringe (34) may be accomplished by using a luer taper connection, suchas a 6 percent luer taper connection. FIG. 44E (and cross section 44F),44I, and 44J illustrate other views of the stabilizer assemblyembodiment. FIG. 44H provides another assembled view, FIG. 44Gillustrates an exploded view, and FIG. 44K illustrates a sectional view,to show the various components of a typical assembly. FIG. 44Lillustrates a close up view of one portion of the sectional view of FIG.44K to illustrate that in one embodiment, a thin layer of polymericmaterial (580), such as Nylon, may be left in place at a locationwherein the needle portion is to stab through the plunger tip (36); thisextra amount of material (580) may be utilized to enhance the loadrequired for push-through of such needle component, and also to enhanceresistance to pulling back the needle out/away from the distal end ofthe plunger tip (36).

Referring to FIG. 45A a needle cover (62) and needle assembly (46) areillustrated similar as to described above, but with certain addedfeatures in the geometry of the mechanical interface. In the depictedembodiment, the needle cover (62) and needle assembly (46) may be joinedby insertion and rotation. The needle assembly (46) and needle cover(62) shown in FIG. 45B illustrate a configuration which may be suitablefor shipping and or storage, wherein the distal housing lug (112) istrapped between the rotational detent (582) and large axial detent (581)such that the needle is contained within the housing and generallycannot be dislodged until the rotational detent (582) has been snappedover. In use, the depicted needle assembly (46) embodiment may becoupled to the luer lock interface (14) of the syringe assembly byapplying a rotational torque to the exterior of the needle cover whichis intercoupled to the needle, while holding still or counterloading thesyringe to counteract the torque applied to the needle cover (62). Amechanical constraint envelope is effectively created by virtue of thedetent interface features (581, 582, 584, 586) to guide the detent intopositions of stability, and also to prevent overtorquing, as shown inFIGS. 45B-45D). One side of the mechanical constraint envelope isdefined by the rotational detent (582), which is snapped over once aminimum amount of torque has been applied to the luer interface by theneedle intercoupled to the needle cover. It is intended that the needlecover cannot be removed from the needle until this rotational detent hasbeen snapped over. This entrapment of the needle within the needle coverprohibits the operator from exposing the needle until a minimum amountof torque has been applied to the luer lock interface from the needlevia the intercoupled needle cover, ensuring a leak free and solidmechanical coupling. A second side of the mechanical constraint envelopeis defined by the second rotational detent (586) which is configured todis-engage the needle cover from the needle once a maximum torque hasbeen reached. This second rotational detent has a surface angled withrespect to the longitudinal axis of the needle and needle cover, whichonce contacted by the distal housing lug (112) imparts an axial force tothe needle cover, dislodging the needle cover from the needle. A thirdside of the mechanical constraint envelope is provided by a smalleraxial detent (584). This axial detent is encountered by the lugs on thedistal housing (112), once the needle has snapped over the first detent(582). The axial detent is intended to provide enough axial force toprevent the needle cover from freely falling off of the needle, whileallowing the user to pull the needle cover off of the needle when theoperator is ready to give the injection. Referring to the close-up viewsof FIGS. 45B-45D, in this embodiment, the lug interface features (112)protruding from the exterior of the distal housing (90) of the needleassembly (46), after being inserted into an appropriate insertionposition relative to the needle cover (62), may be rolled to first crossover a first rotational detent interface feature (582), after which theparticular lug interface feature becomes entrapped (as shown in FIG.45C) between the first rotational detent interface feature (582), andsecond (586) and an axial detent interface feature (584), such that itis essentially in a trapped and stable configuration suitable forremoval of the cover from the needle to expose the needle foruse/injection. In the event that the interface is over-torqued, the luginterface feature (112) will be urged against the third rotationaldetent interface feature (586), which is configured to have a ramp-likegeometry which will cause the needle assembly distal housing (90) to bepushed proximally, in a direction away from the stable coupledconfiguration relative to the needle cover (62).

FIG. 46 illustrates a kit assembly (590) wherein an injection assembly(34, 56, 44) may be packaged with a stabilizer assembly (570) and one ormore needle/needle cover assemblies (62/46). The syringe assembly inFIG. 46 is a manual retraction version of the spring retraction syringeshown above. The plunger rod of this manual retraction syringe may havea latch to prevent re-advancement once the needle has been retractedinto the syringe. The finger flange (56) of this manual retractionsyringe has the threaded interface for connection to the vial accessdevice (570). This finger flange is intended to be single sided, andsnapped on from the side instead of a multi-component clamshell as shownin FIG. 44G.

Referring to FIGS. 47A-47G, a proximal insertion assembly may beutilized to prevent withdrawal of a safety needle configuration untildesired plunger insertion and withdrawal activities have been completed,such as those described above in reference to medicines which must bemixed before injection. Referring to FIG. 47A and the close up view ofFIG. 47B (and FIG. 47C, which is a rotated view of the same assembly ofFIG. 47B), a rotation blocking interface (592) may be utilized totemporarily block or prevent rotation of a latching member (74), toprevent the latch interface feature (122) from engaging the needlewithdrawal mechanism. Referring to FIG. 47D (and rotated view of FIG.47E), upon sufficient relative compressive loading between the flangecoupling assembly (56) and proximal manipulation interface (594), aninterface member (598) with beveled proximal geometry may be utilized toforcibly open a pair of coupling arms (600, 601), such forcing providinga spring-like resistance to the operator. With the movement of theinterface member (598), a slight proximal pulling of the proximalmanipulation interface (594) relative to the housing (596) pulls asecond set of coupling arms (602, 603) over another beveled interface(such forcing providing a spring-like resistance to the operator) andinto a stable and locked position, as shown in FIG. 47F (and rotatedview FIG. 47G) such that the rotation blocking interface (592) is pulledproximally so that it no longer interferes with rotatable action of thelatch member (74), and such that the needle withdrawal mechanism isenabled. Thus without the thoughtful and intentional pulling of theproximal manipulation interface (594) relative to the housing (596)after forcible loading of the flange coupling assembly (56) relative tothe proximal manipulation interface (594), the needle withdrawalmechanism does not become enabled.

Referring to FIGS. 48A-53B, various aspects of safe injectionconfigurations which may be referred to as “staked needle”configurations are illustrated; the “staked needle” denomination relatesto the fact that upon presentation to the user, the injection end of theneedle portion of the syringe or injection assembly of this varietygenerally already is coupled or “staked” relative to the syringe body(34). In other words, relative to various configurations described abovewherein one or more portions of a needle assembly may be removablycoupled to the syringe body (34) at the location of usage (i.e.,immediately prior to usage), in a staked needle configuration the needleis already coupled to the syringe body (34) and in position forinjection, after which it may be safely withdrawn into a protectedconfiguration. Many of the proximal hardware elements from the abovenon-staked configurations may be utilized in the staked needleconfigurations, as evidenced by the common illustration elements andlabels thereof.

Referring to FIGS. 48A-48 k, one staked needle configuration isillustrated wherein upon presentation to the user, the needle assembly,comprising a needle coupling assembly (606; itself comprising a proximalhousing portion 608 and a distal housing portion 610), a needle distaltip (48), a needle joining member (83—see, for example, FIG. 48D), and aneedle proximal end (50) are mounted in position ready for injectionafter removal of a needle cover member (63) which may comprise anelastomeric sealing material on its internal surface to interface withthe needle distal tip (48) during storage. Referring ahead to FIGS. 48Dand 48E, the needle joining member (83) is configured to have anecked-down or radially-reduced portion (111) that is configured tointerface with a latching member (612) and movable block member (614)such that during injection, the needle distal tip (48), needle joiningmember (83), and needle proximal end (50) remain fixed in positionrelative to the syringe body (34), but after complete insertion of theplunger assembly (44) relative to the flange coupling assembly (56)(i.e., after full expulsion of the medicine which may be containedwithin the medicine chamber 40 of the syringe body 34), the movableblock member (614) is advanced relative to the distal housing portion(610) such that the plurality (two are illustrated) of cantileveredlatch members (616) of the latch member (612) are urged out of the wayby the movable block member (614) to allow the needle distal end (48),joining member (83), and proximal end (50) to be retracted through theircoupling (i.e., via the proximal end being stabbed through the plungertip 36 which is being pulled proximally by the springs within theplunger assembly 44 after the plunger assembly spring configuration hasbeen activated by the latching mechanism associated therewith, asdescribed above), thereby placing the needle distal end (48) safelywithin the syringe body (34). In other words, the cantilevered latchmembers (616) retain the position of the needle distal end (48) duringinjection, until they are pushed out of the way by the movable blockmember (614) at full plunger insertion, after which the needle is freeto be withdrawn and the spring withdrawal mechanism within the plungerassembly (44) has been triggered to effect a withdrawal. Referring toFIG. 48C, at initial assembly time (i.e., in the factory or processingfacility—not in the field in a “staked needle” configuration), theproximal housing assembly (608) is configured to snap-fit (i.e., using asnap ring element 604 comprising or coupled to the proximal housingassembly) over a slightly recessed radial portion (602) of the syringebody which is formed into the syringe body upon manufacture of thesyringe body. FIG. 48F illustrates a cross sectional view of suchconstructs in action, and FIGS. 48G-48I illustrate partial orthogonalwireframe views to more directly visualize the latching member (612) andcantilevered members (616) relative to the needle portions (48, 83, 50,111). Referring to FIGS. 48J-48K, in one embodiment, at least oneelongate portion of the plunger assembly may comprise a recessedgeometry (71) configured to provide a limited amount of axial complianceto allow an operator to push the plunger assembly (44) a bit furtheraxially into/relative to the syringe body (34) and flange couplingassembly (56) to ensure that the retraction mechanism becomes fullyswitched by the latching mechanism therein into the mode of retractingthe needle upon full insertion of the plunger tip (36).

Referring to FIGS. 49A-49C, in another embodiment, a needle couplingassembly (620) comprising a proximal housing portion (622) and distalhousing portion (624) is movably coupled about the needle assembly (48,83, 50) and configured to retain the needle in an axially fixed positionfor injection, and then after full insertion of the plunger tip (36),each of a plurality of rotatable members (628) are urged into rotation(630) through interfacing with the interior surface of the distalhousing to rotate protruding portions (632) of the rotatable members(628) out of engagement with the necked-down portion (111) of the needlejoining member (83), thereby allowing for axial motion of the needlejoining member (83) and intercoupled needle distal tip (48) and proximalend (50) to effect retraction into a safe position, as described above.

Referring to FIGS. 50A-50P, another embodiment is shown wherein amovable block member (636) is utilized to urge a latch member (634) outof the way to allow for axial retraction of the needle distal portion(48) into a safe position. FIGS. 50A-50E illustrate a succession ofconfigurations during use; FIGS. 50F, 50H, 50J, 50L, and 50N illustratecross sectional views corresponding to 50A-50E respectively, and FIGS.50G, 50I, 50K, 50M, 50O, and 50P are close-in cross sectional views ofthe views of FIGS. 50F, 50H, 50J, 50L, and 50N, respectively.

FIG. 50A illustrates presentation of an assembly ready for use with aneedle cap (63) in place, coupled to a needle coupling assembly (638).FIG. 50B illustrates the same assembly with the needle cap (63) removed,ready for injection. As shown in the cross sectional views of FIGS. 50Fand 50G, a latch structure (534) is engaged against the recessed ornecked-down portion (111) of the needle joining member (83) to provide atemporary axial fixation of the needle distal tip (48) during injection.FIGS. 50B, 50C, and 50D illustrate injection (i.e., into a patient) withthe plunger member (36) being advanced relative to the syringe body(34). FIG. 50D and related cross sections (FIGS. 50L and 50M) illustratefull injection with the plunger member (36) seated completely into thesyringe body (34) and the movable block member (636) advanced distally,which causes a feature of the movable block member (636) to push thelatch member (634) away from the needle joining member (83, 111),thereby allowing the needle joining member (83) to move axially relativeto the syringe body (34) and be retracted proximally into a safeposition, as shown in FIG. 50E and related cross sections, after whichthe latch member (634) is configured to spring into an occluding shapeto prevent further insertion of the needle distal tip (48). A distal tipportion of the movable block member (636) may be visualized distallyfrom an external perspective, confirming that the syringe has beenutilized. FIG. 50P illustrates that the needle coupling assembly (638)may be coupled to the syringe body (34) using a snap ring (604) fitting(i.e., as interfaced with a slight radially step-recessed portion of thesyringe body 34).

Referring to FIGS. 51A-51H, another safe injection staked needleembodiment is illustrated in sequence, with close-in cross-sectionalviews in FIGS. 51B, 51D, 51F, and 51H, respectively. Referring to FIG.51A, a staked needle syringe assembly is ready for use with the capremoved. A latch structure (652) within the needle coupling assembly(654) holds the needle joining member (83) in an axially fixed locationby mechanically interfacing with the recessed/necked-down portion (111).FIGS. 51C and 51D illustrate injection with axial advancement of theplunger tip (36). Referring to FIGS. 51E and 51F, with completeinsertion of the plunger tip (36) relative to the syringe body (34), themovable block member (656) urges the latch member (652) out of the way,thereby freeing the needle joining member (83) to move axially relativeto the syringe body (34) and be retracted into a safe position whereinfurther insertion of the needle distal portion (48) is blocked. Againthe needle coupling assembly (654) may be joined to the syringe body viaa snap fit using a snap ring.

Referring to FIGS. 52A-52H, another safe injection staked needleembodiment is illustrated in sequence, with close-in cross-sectionalviews in FIGS. 52B, 52D, 52F, and 52H, respectively. Referring to FIG.52A, a staked needle syringe assembly is ready for use with the capremoved. A latch structure (670) within the needle coupling assembly(672) holds the needle joining member (83) in an axially fixed locationby mechanically interfacing with the recessed/necked-down portion (111).FIGS. 52C and 52D illustrate injection with axial advancement of theplunger tip (36). Referring to FIGS. 52E and 52F, with completeinsertion of the plunger tip (36) relative to the syringe body (34), themovable block member (674) urges the latch member (670) out of the way,thereby freeing the needle joining member (83) to move axially relativeto the syringe body (34) and be retracted into a safe position whereinfurther insertion of the needle distal portion (48) is blocked. Againthe needle coupling assembly (672) may be joined to the syringe body viaa snap fit using a snap ring (604).

Referring to FIGS. 53A-53B, it has been described above that oneconfiguration for axially coupling a needle proximal end (50) to aplunger tip (36) is by stabbing through both the compliant butyl rubberor other material, as well as a thin layer of harder material, such as athin layer of polymer (682), as shown in FIG. 53A. FIG. 53B illustratesan alternative configuration wherein the plunger assembly is configuredto comprise two or more cantilevered members (684, 686) configured to berelatively easily crossed in the compressive direction (i.e., during thestabbing-in motion with the needle proximal end 50), and relativelydifficult to decoupled in the axial tension motion (i.e., with a needleretracting load from the plunger assembly to pull the needle distal tipinto a safe configuration).

Referring to FIGS. 54A-58G, various aspects of configurations designedto facilitate injection of multi-part medications are illustrated,wherein two or more medication components are combined to form aninjection combination or solution shortly before delivery into thepatient. In one variation, a liquid diluent (252) may be combined with asubstantially non-liquid form (254), such as a powdered form, of a drugagent, such as a freeze-dried or lyophilized drug component, asdiscussed above, shortly before injection. The configurations describedherein in reference to FIGS. 54A-58G relate to dual-chamberconfigurations, wherein two or more chambers within the same syringebody (34) are utilized to carry, mix, and inject an injection solution.

Referring to FIGS. 54A-54P, various aspects of one variation aredepicted, wherein two chambers are formed by a stopper member (36) inbetween two portions of the interior of a syringe body (34), such that adistal portion contains an air or gas gap, as well as a non-liquidmedication (254); a proximal portion, on the opposite side of thestopper member (36) contains a liquid diluent (252), which is proximallycontained by a second stopper member (32). A cross sectional view isshown in FIG. 54B. Referring to FIG. 54C, and the associated crosssectional view in FIG. 54D, various components of a needle couplingassembly (here a socalled “staked” needle coupling assembly 606 isillustrated, but other needle assemblies as described above, includingLuer-coupled as well as staked configurations, may be utilized). Lugfeatures (258) are configured to assist with coupling the needlecoupling assembly (606) to a needle cover member (65), as shown in FIG.54A, for example. A small O-ring may be utilized as a sealing member(260) around the needle shaft, while a larger O-ring may be utilized asa sealing member (262) at the syringe body (34)/needle coupling assembly(606) interface. Alternatively, the small o-ring (260) and the largeo-ring (262) may be combined into a single seal that performs both ofthe o-ring sealing functions. A proximally located mixing port (270) isconfigured to allow for entry of liquid diluent, to be expelled out of amore distally-located mixing aperture (266); a lumen plug (268)intentionally occludes the needle lumen to create the flow path from theproximal mixing port (270) to the distal mixing aperture (266) underconditions such as those described in reference to FIG. 54M. Referringto FIGS. 54E-54J, various aspects of suitable needle assemblies areillustrated, with several proximal geometric configurations. Referringto FIG. 54E, a proximal harpoon interface (84) is configured to stabinto and couple to a stopper member (32, 36)or with a coupling feature(such as a plunger retraction latching feature; suitable plungerretraction latching features are illustrated, for example, in referenceto the embodiment of FIG. 55G, element 704) in the plunger rod; FIG. 54Fillustrates a spike style harpoon coupling interface (85) that isconfigured to pierce both stopper members (32, 36) and couple with alatching mechanism in the plunger rod to enforce an intercoupling of thetwo stoppers against each other during retraction of the needle memberafter the injection has been given to the patient. FIG. 54G and close-indetail FIG. 54I illustrate a friction bump feature (284) configured toenhance and retain coupling with a stabbed stopper member duringtransfer of liquid from the proximal to the distal portion of thesyringe (34). The section distal to the friction bump feature (284, 286)may be of a reduced outer diameter to decrease the friction as thestopper members (32,36) travel distally during the injection of the drugsolution. FIG. 54H and close-in detail FIG. 54J illustrate a triangularfriction feature (286) configured to enhance and retain coupling with astabbed stopper member. FIGS. 54K-54P illustrate a sequence of actionsfor an injection procedure utilizing a dual chamber configuration suchas that described above. Referring to FIG. 54K, an injection assembly isin a stable configuration wherein it may be shipped or brought to aninjection patient care scenario; a non-liquid drug component (254) isisolated from a liquid diluent component (252), both within a syringebody on opposite sides of a stopper member (36). FIG. 54L illustratesinitial insertion movement of the plunger assembly (44), advancing thedistal (36) and proximal (32) stopper members relative to the syringebody (34). Referring to FIG. 54M, with further advancement, sufficientto stab the proximal end of the needle assembly across the distalstopper member (36), a fluid pathway is formed between the twopreviously isolated chambers of the syringe body (34), such that thediluent fluid (252) may flow into the proximal mixing port and exit themore distal mixing aperture, to reach the non-liquid medicationcomponent (254). FIG. 54N illustrates that with further insertion untilthe stopper members (36, 32) are immediately adjacent each other, thediluent (252) and previously non-liquid component (254) become mixed toform a medication solution (272). Referring to FIG. 54N, with theassembly now ready for injection of the mixed solution (272), the needlecover member (63) may be removed as shown in FIG. 54O and the patientmay be injected with the exposed needle distal end (48). With fulldepression/insertion of the plunger assembly (44) and associated stopperassembly (36, 32) as shown in FIG. 54O, the needle may be retracted to asafe position within the syringe body (34), as described above and shownhere in FIG. 54P.

Existing lyophilization manufacturing processes perform thelyopilization (freeze-drying) of the drug inside of the syringe chamberwhich is sealed proximal to the drug with a stopper and the distal tipof the syringe open, exposing the drug to the lyophilization processthrough the inside diameter (“ID”) of the tip of the syringe. Thisexisting process generally does not allow for the use of traditionalglued-in staked needles, as the needle would have to be in place priorto lyophilization due to the glue curing process. The ID of thetraditional 25 gauge to 34 gauge staked needles are around 0.010″ to0.003″ and generally are too small in cross section to allowlyophilization of the drug in a reasonable time. The staked needleassembly shown in FIGS. 54A-G uses a luer taper tip syringe with a tipID of about 0.040″ that allows for lyophilization. The staked needle ofFIGS. 54A-58G is attached to the syringe via a snap-fit afterlyophilization has taken place, sealing the drug container, and allowingfor the use of the existing lyophilization manufacturing processes.

Referring to FIGS. 55A-55H, various aspects of an embodiment areillustrated wherein a generally cylindrical stopper with an enlargeddistal circumferential surface (274) is configured to separate twosub-chambers of a syringe body (34) when static, but to allow forpassage around of a proximal fluid component (276) when the generallycylindrical stopper (274) is pulled proximally (FIG. 55G depicts aclose-in cross sectional view depicting pass-by flow 276), therebyreducing the effective diameter of its flexible distal portion withenlarged distal circumferential surface (274). Thus, referring to FIG.55C, with the generally cylindrical stopper (274) pulled all the wayproximally (a simplified plunger assembly 45 is shown in FIGS. 55A-55Hfor illustrative purposes, but in other embodiments, retractionassemblies, such as those described above in reference to drawingelement 44 may be utilized) so that the generally cylindrical stopper(274) is interfaced directly with a proximal stopper member (32), fluidpreviously contained between the two stopper members (274, 32) becomesadvanced to the other side of the generally cylindrical stopper (274) sothat it becomes combined with medication elements which may be containedon such other side of the generally cylindrical stopper (274), such asnon-liquid lyophilized drug components. Referring to close-incross-sectional FIGS. 55G and 55H, to facilitate withdrawal of theneedle into the syringe body (34) after patient injection using aplunger assembly configured to automatically withdraw relative to thesyringe body (34) as described above in various embodiments, it may bedesirable to enforce a coupling between the plunger assembly (45) andone or both of the stoppers (32 proximal; 36, 274, or 280 distal) towhich the needle assembly may be coupled (such as by a harpoon-likeproximal needle interface 50, 84) after such injection has beencompleted (i.e., after the plunger assembly has been fully insertedrelative to the syringe body). Referring to the embodiment of FIGS. 55Gand 55H, one or more necked-down or indented features (702) may bepositioned along the plunger assembly (45) such that upon withdrawal(246) of the generally cylindrical stopper (274) for drug mixing beforeinjection, as shown in FIG. 55H, one or more latching members (704)spring down into the indented features to lock the plunger assembly inposition relative to the syringe body (34), such that the two stoppermembers (274, 32) are coupled together by virtue of such latching/indent(704/702) interfacing. With such plunger retraction induced drugcomponent mixing complete, the mixed medication solution may then beinjected by removing the needle cover member (63) and advancing theplunger assembly (45) as shown in FIG. 55E; the generally cylindricalstopper (274) is configured such that the distal circumferential surfacewill seal against the inside of the syringe body (34) when pusheddistally (i.e., this unique stopper is somewhat of a one-way valvecontained within the syringe body and moved by the plunger assembly 45).With full depression/insertion of the plunger assembly (45) andassociated stopper assembly (274, 32), the needle may be retracted to asafe position within the syringe body (34), as described above.

Referring to FIGS. 55I and 55J, an alternative variation is depictedwherein a stopper (288) comprises a valve formed therethrough which maybe opened by pulling or withdrawing (246) the plunger assembly attachedto the stopper (288) relative to the syringe body (34). Referring toFIG. 55I, with substantially no load, or with a pushing load, applied tothe stopper (288) with the plunger assembly (45), fluid is not allowedto pass across the stopper (288). Referring to FIG. 55J, with aretracting or withdrawing (246) load applied to the plunger assembly(45) relative to the syringe body (34), a passageway (298) opens betweenthe main distal stopper body (289) and the distal stopper portion (296)due to transient deformation of the proximal stopper portion (294) suchthat medicinal fluid may flow (300, 301) across the stopper (288)through one or more proximal channels or lumens (292), across the openedpassageway (298), and out the distal channel (290); the structuralmoduli of the materials, as well as the geometries of the features, suchas the proximal stopper portion (294) may be selected specifically tocause this fluid pathway to open during retraction/withdrawal (246) ofthe plunger assembly (45) relative to the syringe body (34), and toclose when not under such loading.

Referring to FIGS. 56A-56F, it may be desirable to physically containthe generally cylindrical stopper (274) after it has been withdrawn tocomplete mixing of the medication components, to minimize insertionfriction during injection of the mixed solution. As shown in FIGS.56A-56C, upon full retraction, the generally cylindrical stopper (274)becomes physically contained within the stopper containment cup (278) sothat upon insertion of the plunger assembly (45), only the proximalstopper member (32) provides a sealing function during injection whilethe generally cylindrical stopper (274) remains contained within thestopper containment cup (278). As shown in FIG. 56F, with fulldepression/insertion of the plunger assembly (45) and associated stopperassembly (274, 32), the needle may be retracted to a safe positionwithin the syringe body (34), as described above.

FIGS. 57A-57C illustrate aspects of a configuration similar to that ofFIGS. 56A-56F, with the exception that the distal stopper membercomprises a generally cylindrical stopper assembly with multiplecircumferentially flared “wiping” edges (280) to facilitate a sealingeffect when pushed distally (i.e., toward the distal needle tip), andalso facilitate fluid passage around such stopper assembly (280) whenwithdrawn proximally. Referring to FIG. 57C, of the distal surface (706)of the stopper assembly (280) is contoured to closely match the theinterfacing surface (708) of the distal end of the interior of thesyringe body (34) to minimize any residual drug in the chamber after theinjection has been performed, ensuring an accurate medicine dosage.

Referring to FIGS. 58A-58G, another dual-chamber embodiment isillustrated wherein rather than allowing for selective fluid passagethrough a portion of the needle to facilitate mixing, as in theembodiment of FIGS. 54A-54P, a syringe body (34) configuration featuresa bypass passageway (282) formed into the particular syringe bodyconfiguration and positioned such that upon insertion of the distalstopper member (36) to a position such as that shown in FIG. 58C, thebypass passageway (282) allows for pressurized fluid to bypass thedistal stopper member (36) and gain access to the previously isolatedother medical component (274) to form a mixed medication solution (272)which may be injected using further insertion of the plunger assembly(44) and associated stopper assembly (36, 32), as shown in FIGS.58D-58F. As described above in reference to the embodiment of FIG. 55G,for example, it may be desirable to have the stoppers (32, 36) becomecoupled to one another to facilitate automatic withdrawal of not onlythe proximal stopper member (32) which is directly coupled to theautomatically retracting plunger assembly (44), but also distal stoppermember (36), to ensure that the needle assembly, which may be coupled tothe distal stopper member (36), or both stopper members (36, 32) iswithdrawn into a safe position at least partially within the syringebody at the appropriate time. Referring to FIGS. 58A and 58B, thedepicted distal stopper member (36) features proximal harpoon-likecoupling members (708) configured to stab into and couple to theproximal stopper member (32) when the two stopper members (36, 32) areurged against each other, such as during the injection as shown in FIG.58F. As shown in FIG. 58G, after full depression/insertion of theplunger assembly (44) and associated stopper assembly (36, 32) to expelthe medication solution (272) into the patient, the needle may beretracted to a safe position within the syringe body (34), as describedabove.

Referring to FIGS. 59A-61S, various embodiments are illustrated whereina significant portion of the safe needle retraction hardware resideswithin a plunger housing. Referring to the embodiment of FIGS. 59A-59L,for example, a safe injection configuration comprises a conventionalsyringe body (34), fitted with a plunger tip (36) configured to bepierced by proximal needle end (50) at an appropriate time to assistwith needle retraction; this plunger tip (36) is coupled to a plungermanipulation interface (128) by a plunger housing member (69) definingan inner volume occupied by various other portions of the assembly, asdescribed below, which are configured to retract the needle at anappropriate time in the sequence of use. A needle coupling assembly(606) similar to those described above in reference to staked needlelatching configurations is included in the illustrated embodiment; otherembodiments may comprise Luer type needle assembly coupling to thesyringe body (34), also as described above. The depicted version of thesyringe body (34) comprises a conventional small-diameter flange (33)geometry which may be manipulated or interfaced between the index andmiddle fingers of the operator, for example, while a thumb of theoperator is interfaced with the plunger manipulation interface (128).FIGS. 59A and 59B illustrate pre-utilization assemblies with a needlecover (63) in place to mechanically isolate the distal needle tip (48).Referring to FIG. 59C, the needle cover (63) has been removed and theassembly is readied for injection into a patient. Referring to FIG. 59D,after the distal needle end (48) has been inserted or stabbed into atissue structure of a patient, the plunger manipulation interface (128)may be briefly pulled away from the syringe body (34) to “aspirate” orcheck to confirm that the needle distal tip (48) has not come to restwithin an unwanted tissue structure portion, such as a vessel. Forexample, if the distal needle tip (48) has come to rest within a vessel,upon slightly pulling out the plunger tip (36), a small marking of bloodof the patient is likely to appear within the medicine chamber (40), andthe operator can see this and reposition the distal needle tip (48).

Referring to FIG. 59E, with the desired distal needle tip positionconfirmed, the plunger manipulation interface (128) is inserted relativeto the syringe body (34) and the medicine is expelled out of themedicine chamber (40), through the needle tip (48), and into thepatient. FIG. 59F illustrates a cross sectional view of theconfiguration of FIG. 59E. Referring to FIG. 59G, with complete seatingof the plunger tip (36) into the syringe body (34), the proximal needleend (50) is stabbed through the plunger tip (36), while elasticdeformation of the material comprising the plunger tip (36) allows theplunger tip to reach the bottom of the syringe body to expel all of themedicine, and trigger the spring to retract the needle while accountingfor geometric variation of syringe body and other components due tomanufacturing and assembly tolerances. Referring to FIG. 59H, needleretention features (712) similar to those (684, 686) described inreference to FIG. 53B are configured to prevent pull-out of the proximalneedle tip (50) once it has been stabbed into and captured by theplunger tip (36). With complete insertion of the plunger tip (36), theneedle latch (616) is configured to become unseated from its previousinterface position (111) against the needle body, as shown in FIG. 59H,to allow for retraction of the needle; concomitantly, as is shown in theprogression from FIGS. 59G/59H to FIGS. 59I/59J, the proximal needle end(50) is configured to directly abut or compress against an unlatchingmember (710) or rod that is configured to allow a rotatable latchingmember (714) to be positioned or configured into either of two states.The first configuration of the rotatable latching member (714), shown inFIG. 59G and associated cross section FIG. 59H, is the “latched”condition, where the rotatable latching member (714) is retained in theposition shown in FIG. 59H by a proximal feature comprising the proximalaspect of the unlatching member (710). In this latched condition, a loadgenerated by a compressed energy-storing member (718), such as a spring,is reacted by the geometric state of the latching member (714),maintaining the compressed state of the energy-storing member (718). Thesecond configuration of the rotatable latching member (714), shown inFIG. 59I and associated cross section FIG. 59J, may be termed the“unlatched” condition wherein the unlatching member (710) has been movedmore proximally with loading from the needle proximal end (50) to causethe rotatable latching member (714) to be free to rotate. In this secondconfiguration, with rotation of the rotatable latching member (714) outof the lock interface window (716) as shown in FIG. 59J, the loadgenerated by the compressed energy-storing member (718) is not reactedby the rotatable latching member (714), and the energy-storing member(718) is free to expand longitudinally, as shown in FIG. 59K andassociated cross section FIG. 59L, thereby pulling the plunger tip (36)proximally, which retracts the needle. Thus referring to FIG. 59J, inthe unlatched configuration, the unlatching member (710) is movedproximally and the rotatable latching member (714) is configured torotate from a latched position, wherein the rotatable latching member(714) is seated within a lock interface window (716), and wherein thisinterfacing of the latch position maintains the energy storage member(718), which may comprise a spring, in a stored configuration, to anunlatched position, wherein the rotatable latching member (714) isrotated slightly out of the lock interface window, as shown in FIG. 59I,and the cross sectional view of FIG. 59J, to free the energy storagemember (718) to accelerate and move the plunger tip (36) to the right asthe potential energy stored in the energy storage member (718) isreleased, thereby pulling the intercoupled proximal needle tip (50)along with it, as shown in FIG. 59K and the cross sectional view of FIG.59L, such that the needle distal tip (48) becomes safely encapsulatedwithin the syringe body (34). As described above, once in thisconfiguration, the needle assembly (606) preferably is configured toprevent any further re-insertion of the distal needle tip (48) relativeto the syringe body (34); in other words, needle tip re-exposure isprevented with such a safety configuration. Referring to FIG. 59M, inone embodiment the plunger tip (36) may be solid, not having anypre-formed through-holes to facilitate transection of the needleproximal end (50). As shown, for example, in FIG. 59L, completeretraction of the needle through the plunger tip (36) requires theneedle to penetrate the plunger tip. To pull the needle through theplunger tip (36) without losing “grip” on the needle proximal end (50),the penetration force of the needle through the plunger tip (36)generally must be low enough so as not to exceed the “gripping load”provided by the interface that has been formed between the proximalneedle tip (50) and the needle retention features (712) with stabbing ofthe proximal needle tip (50) through the plunger tip (36). With oneembodiment, experimentation has shown that the penetration force betweenthe needle assembly and the plunger tip is between about 1 and about 4lbf, depending upon the rubber or elastomeric material used tomanufacture the plunger tip (36). To further minimize resistance as theneedle is pulled through the elastomeric plunger tip (36), in oneembodiment it is desirable to create a chamfered geometry (734) on theproximal geometric aspects of the needle joining member (83), as shownin FIG. 59M.

As was discussed above in reference to FIGS. 59G and 59H, in theembodiment of FIGS. 59A-59M, the elastomeric material comprising theplunger tip (36) is utilized to assist in dealing with slight geometrictolerances which may be present due to manufacturing, assembly,temperature, or other factors. In use, the operator feels the fullinsertion position of the plunger tip (36) relative to the syringe body(34) coming by an increased insertion load required to continueinserting the plunger tip (36). The operator may be trained to continuesuch insertion against such increasing insertion resistance load until a“click” sound is heard, which signifies that the needle latchingmechanism has been triggered, thereby releasing the needlelongitudinally relative to the syringe body so that it may be retracted.Referring to the embodiment of FIGS. 60A-60L, rather than solely relyingupon the elastomeric compliance of the plunger tip (36) for suchgeometric tolerance accommodation, a coupling member (722) may bemovably intercoupled between the plunger tip (36) and the plungerhousing (67) such that a gap (720, as shown, for example, in FIG. 60F)is retained until a certain insertional load is obtained, after whichthis gap (720) is closed by virtue of the proximal end of the couplingmember (722) sliding to the right relative to plunger housing (67), toeliminate the gap, as shown in FIG. 60G and associated cross sectionalview, FIG. 60H. FIGS. 60A and 60B illustrate such an injection assemblyready to use with a protective cap (63) isolating the distal needle tip(48). FIG. 60C illustrates the protective cap (63) removed, ready forinjection. FIG. 60D illustrates an aspiration step, as described above,wherein the plunger may be pulled backwards relative to the patient toconfirm needle location.

Thus in operation, upon full insertion of the plunger tip (36) relativeto the syringe body (34), several things happen: the needle latching(616) mechanism becomes unlatched, allowing for retraction of theneedle; the insertional load threshold is passed, causing the couplingmember (722) to collapse the gap (720) and allow for full capture of theneedle proximal end (50) by the capturing features (712), andcompressive loads from the needle proximal end (50) abutting theunlatching member (710) cause the rotatable latching member (714) to befree to rotate out of the latched position relative to the lockinterface window (716) defined into the plunger housing member (67), asshown in FIG. 60I and associated cross sectional view FIG. 60J; FIG. 60Kand associated cross sectional view FIG. 60L illustrate the condition ofthe assembly after the needle has been retracted such that the distalneedle tip (48) is housed within the syringe body (34).

Referring to FIGS. 61A-61S, in another embodiment, configurationssimilar to those of FIGS. 59A-59L, or 60A-60A, but without the syringebody flange (33), may be utilized with “pen” or “re-use” housinginterfaces, such as those depicted in FIGS. 61C, 61F, 61I, 61L, 61O, and61R. Referring to FIG. 61A, a safe injection configuration similar tothat of FIG. 59A is depicted, with the exceptions that the embodiment ofFIG. 61A has a syringe body (34) that does not incorporate a proximalflange (element 33 of FIG. 59A), and has a plunger housing (69) withouta manual manipulation interface (element 128 of FIG. 59A)—and rather hasa proximal end (129) configured to be interfaced with a plunger couplingmember (730) distal end of a pen or re-use housing configuration. FIG.61B illustrates a cross sectional view of the configuration of FIG. 61A.As shown in the assembly view of FIG. 61C, the configuration of FIG. 61Amay be at least temporarily housed within the pen or re-use housingassembly; the depicted pen or re-use housing assembly comprises a distalhousing portion (726) defining a window (724) therethrough to visualizethe injection components therein; a proximal housing portion (728) ismovably coupled to a plunger coupling member (730), the distal portionof which is removably coupleable to the plunger housing (69) proximalend (129); a plunger manipulation interface (732) is coupled to theproximal end of the plunger coupling member (730). FIGS. 61D, 61E, and61F illustrate similar configurations as those of FIGS. 61A, 61B, and61C, respectively, with the protective needle cap (63) removed, and theneedle distal tip (48) ready for injection. Referring to FIGS. 61G, 61J,and 61M (and, respectively, injection assembly cross sections 61H, 61K,and 61N, and pen or re-use housing assembly integration cross sections61I, 61L, and 61O), the injection assembly is operated as described inrelation to FIGS. 59E/59F, 59G/59H, and 59I/59J, with exception that themanual manipulation by the user is not direct to the injection assembly,but is rather to the pen or re-use housing, which is at leasttemporarily coupled to the injection assembly. Upon full insertion ofthe plunger tip (36), the needle becomes unlatched and is capturedproximally by the plunger tip (36), and loading of the proximalrotatable latch member (714) causes retraction of the needle, as shownin FIGS. 61P, 61Q, and 61R, leaving a safely used and disposableinjection assembly cartridge, as shown in FIG. 61S. Referring back toFIGS. 61H and 61I, the syringe body (34), such as one constructed from aglass material, may comprise a Luer taper on one end for attachment ofthe staked needle assembly, such as the staked needle assembly (606)described above. In an alternate embodiment, cartridge syringe body maybe utilized which has a glass flange configuration, similar to that on amedicine vial, which consists of a rubber seal and an aluminum crimp toseal the medicine inside the glass cartridge. With such an embodiment, aneedle configuration similar to that shown in FIG. 61I may be snappedover the glass flange to seal the medicine in the cartridge; thealuminum crimp may be replaced with a plastic needle housing.

As noted above, while the configurations of FIGS. 59A-61S areillustrated using a staked needle needle housing/latch configuration asdescribed in detail here, such configurations may also utilize Luer typecoupling and associated hardware, also as described in detail here. Incertain circumstances, the staked needle configurations may be desiredfor properties such as glue/adhesive free nature of the describedembodiments, silicone films which may be “baked on” due to the fact thatadhesive-free staked coupling configurations may not be as limiting ontemperatures during processing, and also the tungsten-free nature of theaforementioned staked needle coupling configurations, wherein preferablythere is no tungsten pin exposure for forming a needle aperture, as theaforementioned staked coupling configurations utilize Luer-style syringebodies even for staked coupling, and may be completed usingtungsten-free rods.

Various exemplary embodiments of the invention are described herein.Reference is made to these examples in a non-limiting sense. They areprovided to illustrate more broadly applicable aspects of the invention.Various changes may be made to the invention described and equivalentsmay be substituted without departing from the true spirit and scope ofthe invention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processact(s) or step(s) to the objective(s), spirit or scope of the presentinvention. Further, as will be appreciated by those with skill in theart that each of the individual variations described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinventions. All such modifications are intended to be within the scopeof claims associated with this disclosure.

Any of the devices described for carrying out the subject diagnostic orinterventional procedures may be provided in packaged combination foruse in executing such interventions. These supply “kits” may furtherinclude instructions for use and be packaged in sterile trays orcontainers as commonly employed for such purposes.

The invention includes methods that may be performed using the subjectdevices. The methods may comprise the act of providing such a suitabledevice. Such provision may be performed by the end user. In other words,the “providing” act merely requires the end user obtain, access,approach, position, set-up, activate, power-up or otherwise act toprovide the requisite device in the subject method. Methods recitedherein may be carried out in any order of the recited events which islogically possible, as well as in the recited order of events.

Exemplary aspects of the invention, together with details regardingmaterial selection and manufacture have been set forth above. As forother details of the present invention, these may be appreciated inconnection with the above-referenced patents and publications as well asgenerally known or appreciated by those with skill in the art. Forexample, one with skill in the art will appreciate that one or morelubricious coatings (e.g., hydrophilic polymers such aspolyvinylpyrrolidone-based compositions, fluoropolymers such astetrafluoroethylene, hydrophilic gel or silicones) may be used inconnection with various portions of the devices, such as relativelylarge interfacial surfaces of movably coupled parts, if desired, forexample, to facilitate low friction manipulation or advancement of suchobjects relative to other portions of the instrumentation or nearbytissue structures. The same may hold true with respect to method-basedaspects of the invention in terms of additional acts as commonly orlogically employed.

In addition, though the invention has been described in reference toseveral examples optionally incorporating various features, theinvention is not to be limited to that which is described or indicatedas contemplated with respect to each variation of the invention. Variouschanges may be made to the invention described and equivalents (whetherrecited herein or not included for the sake of some brevity) may besubstituted without departing from the true spirit and scope of theinvention. In addition, where a range of values is provided, it isunderstood that every intervening value, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention.

Also, it is contemplated that any optional feature of the inventivevariations described may be set forth and claimed independently, or incombination with any one or more of the features described herein.Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin claims associated hereto, the singular forms “a,” “an,” “said,” and“the” include plural referents unless the specifically stated otherwise.In other words, use of the articles allow for “at least one” of thesubject item in the description above as well as claims associated withthis disclosure. It is further noted that such claims may be drafted toexclude any optional element. As such, this statement is intended toserve as antecedent basis for use of such exclusive terminology as“solely,” “only” and the like in connection with the recitation of claimelements, or use of a “negative” limitation.

Without the use of such exclusive terminology, the term “comprising” inclaims associated with this disclosure shall allow for the inclusion ofany additional element—irrespective of whether a given number ofelements are enumerated in such claims, or the addition of a featurecould be regarded as transforming the nature of an element set forth insuch claims. Except as specifically defined herein, all technical andscientific terms used herein are to be given as broad a commonlyunderstood meaning as possible while maintaining claim validity.

The breadth of the present invention is not to be limited to theexamples provided and/or the subject specification, but rather only bythe scope of claim language associated with this disclosure.

What is claimed:
 1. A system for injecting, comprising: a. a syringebody defining an interior medicine chamber and a distal needleinterface; b. a stopper member configured to be inserted into theinterior medicine chamber to contain medicine within the medicinechamber; c. a plunger member configured to be manually manipulated toinsert the stopper member relative to the syringe body; and d. a needlehaving proximal and distal ends, the proximal end being removablycoupled to the distal needle interface of the syringe body and at leastpartially retractable into the interior medicine chamber uponmanipulation of the plunger member relative to the syringe body totransform a plunger latching member from a latched state to an unlatchedstate, the plunger latching member intercoupled between the syringe bodyand the plunger member; wherein the plunger latching member issubstantially disposed within a lumen defined by the plunger member. 2.The system of claim 1, wherein the syringe body comprises anoff-the-shelf syringe body.
 3. The system of claim 1, wherein thesyringe body comprises a generally cylindrical geometry.
 4. The systemof claim 1, wherein the medicine chamber is configured to containbetween about 0.5 cc and about 5 cc of medicine.
 5. The system of claim4, wherein the medicine chamber is configured to contain a volume ofmedicine selected from the group consisting of: 0.5 cc, 1 cc, 2.25 cc, 3cc, and 5 cc.
 6. The system of claim 1, wherein the syringe bodycomprises a glass material.
 7. The system of claim 1, wherein thesyringe body comprises a polymeric material.
 8. The system of claim 7,wherein the polymeric material is selected from the group consisting of:COP, COC, polyester, and polypropylene.
 9. The system of claim 1,wherein the syringe body comprises a metal.
 10. The system of claim 1,wherein the syringe body comprises a distal outer geometry configured tobe mechanically coupled to one or more other device elements.
 11. Thesystem of claim 10, wherein the syringe body distal outer geometrycomprises a luer lock interface.
 12. The system of claim 10, wherein thesyringe body distal outer geometry comprises a luer taper interface. 13.The system of claim 1, wherein the syringe body defines a distalmedicine port.
 14. The system of claim 13, wherein the needle has amaximum outside diameter selected to be insertable through the distalmedicine port of the syringe body.
 15. The system of claim 14, whereinthe distal medicine port comprises an inner diameter of about 1 mm. 16.The system of claim 15, wherein the needle has a size between about 34gauge and about 20 gauge.
 17. The system of claim 1, wherein the stoppermember is configured to be at least partially pierced by a sharpenedproximal end of the needle.
 18. The system of claim 1, wherein theneedle has at least one anchoring element configured to resist pulloutsubsequent to being at least partially pierced into the stopper member.19. The system of claim 18, wherein the at least one anchoring elementis selected from the group consisting of: a barb, a skive cut, hookgeometry, an arrowhead geometry, an undulating radius geometry, anexpandable faceted barb configuration, and a deformable memberconfigured to be insertable in a relatively small cross-sectional stateand to be deformed to a larger cross-sectional state.
 20. The system ofclaim 1, wherein the stopper has an outer geometry selected tosubstantially match an inner geometry of the syringe body tosubstantially seal with the syringe body.
 21. The system of claim 1,wherein the stopper comprises an elastomeric material selected from thegroup consisting of: chlorobutyl rubber, bromobutyl rubber, and siliconrubber.
 22. The system of claim 1, further comprising a sealant coatingapplied to at least a portion of the stopper to isolate medicinematerials from the stopper.
 23. The system of claim 22, wherein thesealant coating comprises a PTFE film.
 24. The system of claim 1,further comprising a lubricant layer introduced between the stopper andthe syringe body.
 25. The system of claim 24, wherein the lubricantlayer comprises silicon oil.
 26. The system of claim 1, wherein a distalportion of the stopper member comprises a conventional off-the-shelfcompliant stopper.
 27. The system of claim 26, wherein the stoppermember comprises an unmodified solid compliant member with no recessesor projections for coupling to a needle.
 28. The system of claim 1,wherein the needle comprises at least one radially-projecting latchingsurface feature.
 29. The system of claim 28, wherein the proximal end ofthe needle comprises at least one piercing element located proximallyrelative to at least one anchoring element.
 30. The system of claim 29,wherein the piercing element comprises a sharpened tip.
 31. The systemof claim 30, wherein the piercing element comprises a solid constructionwithout a lumen or aperture defined therethrough.
 32. The system ofclaim 29, wherein the needle defines an injection passage therethrough,the injection passage selected to lead from the distal tip of the needleto a location proximal to that of the anchoring element.
 33. The systemof claim 28, wherein the needle comprises a cannula member, a hubmember, and a proximal member.
 34. The system of claim 33, wherein thecannula member and hub member are formed from the same piece ofmaterial.
 35. The system of claim 33, wherein the cannula member and hubmember comprise separately formed elements that are fixedly coupledtogether to form portions of the needle.
 36. The system of claim 33,wherein the proximal member also comprises a separately formed elementthat is fixedly coupled to the cannula member and hub member to form aportion of the needle.
 37. The system of claim 35, wherein the hubmember is formed from a piece of tubing.
 38. The system of claim 33,wherein the proximal member comprises a piece of flat sheet metal havinga proximal coupling interface.
 39. The system of claim 32, wherein thecannula member comprises a metal.
 40. The system of claim 32, whereinthe hub comprises a metal or plastic material.
 41. The system of claim32, wherein the proximal member a metal or plastic material.
 42. Thesystem of claim 1, further comprising an energy-storing memberoperatively coupled between the stopper member and the syringe body, theenergy-storing member configured to facilitate retraction of the stoppermember relative to the syringe body.
 43. The system of claim 42, whereinthe plunger member comprises a plunger member body that defines aninterior volume, and wherein the energy-storing member is housedsubstantially inside of the plunger member body interior volume.
 44. Thesystem of claim 43, further comprising a latch member operativelycoupled to the plunger member and housed substantially within theplunger member body interior volume, the latch member being configuredto have a first mechanical state wherein the latch member maintains theenergy storing member in an energy-storing state, and a secondmechanical state wherein the latch member allows the energy-storingmember to release energy stored by the energy-storing member to assistin retraction of the stopper member relative to the syringe body. 45.The system of claim 44, wherein the latch member comprises triggeringportion configured to extend outside of the plunger member body interiorvolume and operatively couple to the syringe body such that theenergy-storing member may be automatically released when the plungermember and intercoupled stopper member reach a predetermined insertionalposition relative to the syringe body.
 46. The system of claim 45,wherein the predetermined insertional position is one wherein thestopper is positioned in a full insertion state relative to the syringebody.
 47. The system of claim 42, wherein the energy-storing member is aspring.
 48. The system of claim 47, wherein the spring comprises amaterial selected from the group consisting of: stainless steel, carbonsteel, beryllium copper alloy, nickel-titanium alloy, chrome-siliconalloy, and cobalt-nickel alloy.
 49. The system of claim 47, wherein thespring comprises an elastomeric polymer.
 50. The system of claim 49,wherein the elastomeric polymer is selected from the group consistingof: a styrenic polymer, a co-polyester polymer, polyurethane, polyamide,a polyolefin blend, a polyolefin alloy, a polyolefin plastomer, apolyolefin plastomer, and rubber.
 51. The system of claim 42, whereinthe energy-storing member comprises a solid pellet member.
 52. Thesystem of claim of 51, wherein the solid pellet member is an elastomericpolymer selected from the group consisting of: a styrenic polymer, aco-polyester polymer, polyurethane, polyamide, a polyolefin blend, apolyolefin alloy, a polyolefin plastomer, a polyolefin plastomer, andrubber.
 53. The system of claim 47, wherein the spring comprises asingle generally helically-shaped coil.
 54. The system of claim 47,wherein the spring comprises a plurality of generally helically-shapedcoils.
 55. The system of claim 54, wherein at least two of the coilscomprising the plurality of generally helically-shaped coils areco-axially aligned.
 56. The system of claim 54, wherein at least two ofthe coils comprising the plurality of generally helically-shaped coilsare longitudinally parallel aligned.
 57. The system of claim 55, whereinthe co-axially aligned helically-shaped coils are also longitudinallyparallel aligned.
 58. The system of claim 57, wherein the co-axially andlongitudinally parallel aligned helically-shaped coils are helicallywound with opposite winding directions relative to each other to preventcoil interference upon compression of the coils.
 59. The system of claim42, wherein retraction of the plunger retracts the intercoupled stoppermember and needle, such that at least a portion of the needle iswithdrawn into the interior medicine chamber of the syringe body. 60.The system of claim 1, wherein the plunger comprises a proximal thumbpad configured to facilitate manual insertion and retraction control ofthe plunger relative to the syringe body.
 61. The system of claim 1,wherein the plunger comprises a plunger distal end screw interfaceconfigured to be helically inserted into the stopper member and coupledthereto by virtue of such insertion.
 62. The system of claim 1, whereinthe plunger member comprises a plurality of ratchet features positionedon a surface of the plunger member, the ratchet features configured toprevent re-insertion of the plunger member relative to the syringe bodyafter the plunger member has initially been inserted to a predeterminedposition relative to the syringe body.
 63. The system of claim 62,wherein the predetermined position is one wherein the stopper member hasbeen advanced to a fully-inserted position by the plunger memberrelative to the syringe body.
 64. The system of claim 62, furthercomprising a latch member operatively coupled between the plunger memberand the syringe body, wherein the latch comprises at least one ratchettooth engageable with the ratchet features, as well as a proximalinterface engageable with a handle portion of the syringe body.
 65. Thesystem of claim 44, further comprising a trigger engagement membercoupled to the syringe body and configured to engage the triggeringportion of the latch member through a trigger engagement window definedthrough at least a portion of the plunger member.
 66. The system ofclaim 1, further comprising a proximal seal configured to encapsulatethe stopper member within the interior medicine chamber of the syringebody such that a vacuum load is developed as the stopper is insertedinto the interior medicine chamber.
 67. The system of claim 66, furthercomprising a braking member operatively coupled to the plunger memberand the syringe body, the braking member configured to facilitateinsertion of the plunger member relative to the syringe body, but toresist retraction of the plunger member relative to the syringe body ina first mode until the braking member has been placed in a releasedbraking configuration second mode.
 68. The system of claim 67, whereinthe braking member comprises a plate-aperture brake.
 69. The system ofclaim 68, wherein the plate-aperture brake comprises a piece of sheetmetal with an aperture formed therethrough.
 70. The system of claim 68,further comprising a spring member configured to facilitate retractionof the plunger relative to the syringe body after the plunger has beenfully inserted relative to the syringe body.
 71. The system of claim 70,wherein the plate-aperture brake is configured to switch from the firstmode to the second mode by inducing plastic deformation of at least aportion of the spring member.
 72. The system of claim 67, whereinretraction of the plunger member is facilitated in the second modethrough application of a retraction starter load.
 73. The system ofclaim 72, wherein the retraction starter load is applied by a springmember operatively coupled to the braking member.
 74. The system ofclaim 72, wherein the retraction starter load is applied by a springmember coupled between the plunger member and the syringe body.
 75. Thesystem of claim 73, wherein the spring member is selected from the groupconsisting of: a coil spring, a leaf spring, and an elastomeric springelement.
 76. The system of claim 74, wherein the spring member isselected from the group consisting of: a coil spring, a leaf spring, andan elastomeric spring element.
 77. The system of claim 66, wherein thevacuum load is sufficient to at least partially retract the plungerrelative to the syringe body.
 78. The system of claim 77, whereinretraction of the plunger retracts the intercoupled stopper member andneedle, such that at least a portion of the needle is withdrawn into theinterior medicine chamber of the syringe body.
 79. The system of claim1, further comprising a needle cover member defining an inner volumeconfigured to temporarily house and protect at least a sharpened distalend of the needle, while also aligning a sharpened proximal end of theneedle for interfacing with the syringe body when installed by a user.80. The system of claim 79, wherein the needle cover member is removablycoupled to the needle with at least one snap-over detent interface. 81.The system of claim 80, wherein the needle cover member is removablycoupled to the needle with at least two snap-over detent interfaces. 82.The system of claim 81, wherein a snap-over detent interface is orientedto prevent rotation of the needle cover member about an axissubstantially aligned with that of the needle until the detent has beenmechanically overcome with a torsional load.
 83. The system of claim 81,wherein a snap-over detent interface is oriented to prevent axial motionof the needle cover member relative to the needle until the detent hasbeen mechanically overcome by an axial load.
 84. The system of claim 79,wherein the inner volume of the needle cover member comprises aplurality internally-facing radial projection surfaces configured toguide the sharpened proximal end of the needle relative to the syringebody as the needle and syringe body are being manually intercoupled. 85.The system of claim 1, wherein medicine chamber is defined by a chamberlength, and the needle is defined by a needle length that is equal to orlonger than the chamber length.
 86. The system of claim 85, furthercomprising an extension member coupled to a proximal end of the syringebody, the extension member operatively coupled to the plunger member andconfigured to house at least a portion of the needle when the needle iswithdrawn entirely into a volume defined by the interior medicinechamber and the extension member.
 87. The system of claim 1, furthercomprising an extension member coupled to a proximal end of the syringebody, the extension member operatively coupled to the plunger member andconfigured to contain the stopper member if the stopper is withdrawn tosuch an extent that it at least partially exits the interior medicinechamber, the extension member comprising a fluid containment surfacepositioned immediately adjacent the distal surface upon withdrawal ofthe stopper member into the extension chamber, the fluid containmentsurface configured to contain residual droplets of medicine which mayremain coupled to the distal surface of the stopper member until theybecome contained by the fluid containment surface.
 88. The system ofclaim 1, wherein the plunger member is configured to be manuallyretracted by an operator when the plunger latching member is in theunlatched state.
 89. The system of claim 88, wherein the distal end ofthe needle becomes structurally encapsulated within the interiormedicine chamber.
 90. The system of claim 88, wherein the distal end ofthe needle becomes structurally encapsulated by a needle door membermovably coupled the syringe body and configured to have a first statewherein the needle door member facilitates insertion of the needlerelative to the syringe body, and a second state wherein the needle doormember prevents insertion of the needle relative to the syringe body.